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Intramuscular Ketamine Effect on Postnasal Surgery Agitation: A Prospective Double-Blinded Randomized Controlled Trial

Intramuscular Ketamine Effect on Postnasal Surgery Agitation: A Prospective Double-Blinded... Hindawi Anesthesiology Research and Practice Volume 2023, Article ID 2286451, 6 pages https://doi.org/10.1155/2023/2286451 Research Article Intramuscular Ketamine Effect on Postnasal Surgery Agitation: A Prospective Double-Blinded Randomized Controlled Trial 1 1 1 1 Husam A. Almajali , Ali M. Abu Dalo , Nidal M. Al-Soud , Ali Almajali , 2 1 1 Abdelrazzaq Alrfooh , Thani Alawamreh , and Hamza Al-Wreikat Department of Anaesthesia and Intensive Care, Jordanian Royal Medical Services, Amman, Jordan Department of ENT, Jordanian Royal Medical Services, Amman, Jordan Correspondence should be addressed to Husam A. Almajali; dr.majali1@yahoo.com and Ali M. Abu Dalo; a.ad_91@yahoo.com Received 3 December 2022; Revised 16 February 2023; Accepted 17 February 2023; Published 27 February 2023 Academic Editor: Ronald G. Pearl Copyright © 2023 Husam A. Almajali et al. Tis is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Tis study investigates the efect of intramuscular ketamine on emergence agitation (EA) following septoplasty and open septorhinoplasty (OSRP) when administered at subanesthetic doses at the end of surgery. A random sample of 160 ASA I-II adult patients who underwent septoplasty or OSRP between May and October, 2022, was divided into two groups of eighty patients each: ketamine (Group K) and saline (Group S) with the latter serving as the control group. At the end of surgery immediately after turning of the inhalational agent, Group K was administered with intramuscular 2 ml of normal saline containing 0.7 mg/kg ketamine and Group S with 2 ml of intramuscular normal saline. Sedation and agitation scores at emergence from anesthesia were recorded after extubation using the Richmond Agitation-Sedation Scale (RASS). Te incidence of EA was higher in the saline group than in the ketamine group (56.3% vs. 5%; odds ratio (OR): 0.033; 95% confdence interval (CI): 0.010–0.103; p< 0.001). Variables associated with a higher incidence of agitation were ASA II classifcation (OR: 3.286; 95% (CI): 1.359–7.944; p � 0.008), longer duration of surgery (OR: 1.010; 95% CI: 1.001–1.020; p � 0.031), and OSRP surgery (OR: 2.157; CI: 1.056–5.999; p � 0.037). Te study concluded that the administration of intramuscular ketamine at a dose of 0.7 mg/kg at the end of surgery efectively reduced the incidence of EA in septoplasty and OSRP surgery. ENT surgeries, current smoking, and the presence of a tra- 1. Introduction cheal tube [2, 4]. Dealing with an agitated patient can be challenging. Although EA spontaneously resolves typically after Emergence agitation (henceforth, EA) is a postanesthetic a short period [5], it may lead to serious consequences such phenomenon characterized by restlessness, excitation, and as bleeding, self-extubation, prolonged hospital admission, confusion during early recovery from general anesthesia [1] and injury to the patient and theatre staf [6, 7]. Tus, in around 22.2% of patients[2]. Te precise cause of EA is eliminating risk factors and adequate postoperative pain still unknown, since one retrospective cohort study attrib- control leading to the efective prevention of EA will im- uted EA to the sense of sufocation caused by nasal packing prove clinical outcomes [2]. following surgeries [3], and another claimed the opposite, Studies have investigated diferent drugs and found some i.e., nasal packing did not increase the incidence of EA [4]. to be efective in EA prevention including opioids, alpha 2 Other potential risk factors include ASA (American Society receptor agonists such as dexmedetomidine, and ketamine of Anesthesiologists) physical status ≥2, young age, post- [3, 9, 10]. Ketamine, an N-methyl-D-aspartate (NMDA) operative pain, male gender, inhalational anesthesia, post- receptor antagonist used as an anesthetic agent, has an operative nausea and vomiting (PONV), oral cavity and analgesic efect at subanesthetic doses [10]. Te peak plasma 2 Anesthesiology Research and Practice Enrollment Assessed for eligibility (n= 193) Excluded (n=33) (i) Not meeting inclusion criteria (n=33) (ii) Declined to participate (n=0) (iii) Other reasons (n=0) Randomized (n=160) Allocation Allocated to Group-K (n=80) Allocated to Group-S (n=80) (i) Received allocated intervention (n=80) (i) Received allocated intervention (n=80) (ii) Did not receive allocated intervention (n=0) (iii) Did not receive allocated intervention (n=0) Follow-Up Lost to follow-up (n=0) Lost to follow-up (n=0) Discontinued intervention (n=0) Discontinued intervention (n=0) Analysis Analysed (n=80) Analysed (n=80) (i) Excluded from analysis (n=0) (i) Excluded from analysis (n=0) Figure 1: Consort fow diagram. concentrations of ketamine following IV and IM adminis- patients scheduled for septoplasty or open septorhinoplasty tration occur within 1 to 5 minutes, respectively [11]. To the who were frst assessed for eligibility which resulted in the best of the researchers’ knowledge, the efect of ketamine on exclusion of 33 patients: 17 with a BMI <20 or >30, 8 under EA following nasal surgeries has been investigated only 18 years of age, 4 with a history of hypertension, 3 with when it was intravenously administered. a psychiatric problem, and 1 with morphine allergy. Te 160 Tis study investigates the efect of ketamine on EA patients were randomly distributed into two equal groups: following septoplasty and open septorhinoplasty (henceforth, the ketamine group (Group K) and the saline (Group S) OSRP) when intramuscularly administered at subanesthetic group. Te demographical and clinical data are summarized doses to reduce the incidence of EA. Te researchers resorted in Table 1. to intramuscular ketamine injection to reduce the incidence Random Allocation software was used to provide simple of EA without causing signifcant sedation and without in- random codes for ketamine and normal saline syringes, all of creasing the response time to verbal stimulus, as drug ab- which were prepared and sealed in sequentially coded sorption and the onset of action will be slower than the IV identical opaque containers as per the allocation sequence of route investigated earlier [9]. Te primary outcome of the the specialist physician who partook in the randomization study was developing agitation (RASS≥ 2), and the secondary process and was excluded from the follow-up. Te anesthetic is the numerical rating scale of pain (NRS) ≥5. nurse provided the sequential opaque container just before turning of the inhalational agent, and the researchers 2. Materials and Methods documented the syringe code. Patients, researchers, out- come assessors, and anesthetic nurses were all kept blinded Tis multicenter randomized study, the steps of which are for allocation. given in Figure 1, was performed between May and October, 2022, after it was approved by the Royal Medical Services Human Research Ethics Committee (registration number 2.1. General Anesthesia and Surgical Procedure. Te patients NCT05313659 at https://clinicaltrials.gov). Te sample in- were taken to the operating room without any premed- ication. Standard AAGBI monitors were used. Anesthesia cluded patients aged 18–64 with ASA physical status I-II scheduled for septoplasty and OSRP from whom a written was intravenously induced by 1.5 μg/kg fentanyl, 2 mg/kg propofol, and 0.6 mg/kg rocuronium which was maintained consent was obtained. Patients with ketamine or morphine allergies, a history of cardiac, neurological, or psychiatric through a mixture of 50% oxygen and 1.2% isofurane in the disease, glaucoma, and a body mass index of less than 20 or air at a fow rate of 2.5 L/min. For intraoperative analgesia more than 30 kg/m were excluded. and hypotensive technique, remifentanil infusion at a rate of To achieve the purpose of the study using the GPower 0.05–2 μg/kg/min was used. Following intubation, all pa- computer program, considering alpha set at 0.05 with tients received 8 mg of dexamethasone as prophylaxis for medium efect size, a study power of 80%, and a sample size postoperative nausea and vomiting (henceforth, PONV). of 158 and 79 in each group was deemed suitable. Tus, the Te ventilator parameters were adjusted at a tidal volume of researchers opted for a sample of 160 patients, from the 193 7–10 ml/kg and a respiratory rate of 10–12 breaths/min to Anesthesiology Research and Practice 3 Table 1: Demographical and clinical data of the sample. A p value of <0.05 was considered statistically signif- cant. Statistical analyses were performed using the SPSS for Study’s arms (N � 160) Windows (version 28; IBM Corporation). Variables Category N (%) Ketamine Saline n (%) n (%) 3. Results Male 85 (53.1) 43 (53.8) 42 (52.5) Gender Female 75 (46.9) 37 (46.3) 38 (47.5) As given in Table 3, the bivariate analysis shows that the Septoplasty 82 (51.2) 41 (51.2) 41 (51.2) incidence of EA in the saline group was 56.3% but only 5% in Surgery OSRP 78 (48.8) 39 (48.8) 39 (48.8) the ketamine group (p≤ 0.001). I 71 (44.4) 35 (43.8) 36 (45.0) Te other variables with signifcant diferences between ASA II 89 (55.6) 45 (56.3) 44 (55.0) agitated and nonagitated patients were ASA physical status Age (years) Mean± SD 28± 7.9 27.2± 7.5 28.8± 8 classifcation (p � 0.020), age (p � 0.034), pain score BMI Mean± SD 24± 2.9 24.2± 2.9 23.9± 2.9 (p � 0.006), and duration of surgery (p � 0.029). In addition OSRP � open septorhinoplasty; ASA � American Society of Anesthesiolo- to these fve variables, an extra variable associated with EA gists physical status classifcation; BMI � body mass index. (p≤ 0.2) in the bivariate analysis (the type of surgery) was entered into the multivariate backward binary logistic re- gression model, and the following four variables were found maintain the end-tidal CO2 levels of 30–35 mmHg. Remi- to be signifcantly associated with EA: study arms, ASA fentanil infusion was stopped 10 minutes before the end of physical status classifcation, duration of surgery, and type of the surgery to prevent any delay in the emergence from surgery, as shown in Table 4. Te EA odds were 0.033 times anesthesia. At the end of the surgery immediately after the lower in Group K than in Group S which means that the inhalational agent was discontinued, 2 ml of normal saline incidence of EA has been reduced by 96.7% in Group K. containing 0.7 mg/kg of racemic ketamine was in- On the other hand, the EA odds were 3.3 times higher in tramuscularly administered to Group K, and only 2 ml of ASA II than in ASA I, and 2.2 times higher in OSRP than in normal saline was administered to Group S using a 3 ml septoplasty surgery. Tey were also expected to increase by syringe. Te injection site of both groups was the lateral 1.01 times per minute for the duration of the surgery. thigh. For postoperative analgesia, 0.07 mg/kg of in- Table 5 shows the time taken to obtain a response to travenous morphine was also administered when the in- verbal stimuli after extubation, the incidence of post- halational agent was turned of, and a nasal pack was used for operative pain, PONV, and additional antiemetic re- all patients. Te patients were ventilated with 100% oxygen quirements in the PACU. While the time taken to obtain at a fow rate of 7 l/min and then extubated once they met a verbal response to verbal stimuli was higher in Group K extubation criteria. (p< 0.002) with a mean diference of 0.48 minutes Te patients’ EA level was evaluated using the Richmond (29 seconds), but the postoperative pain score was signif- Agitation-Sedation Scale (RASS) immediately after extu- cantly lower in this group than that of Group S (p< 0.001). bation until they were handed over to the postanesthaesia Tere were no statistically signifcant diferences between the care unit (henceforth, PACU), and the highest score study arms when considering PONV occurrence and ad- documented, is shown in Table 2 (adapted from [12]). For ditional antiemetic requirements in the PACU. the purpose of this study, patients with a RASS score of +2 or more were considered to have EA. During the frst 30 minutes in the PACU, the pain score 4. Discussion was evaluated using the numerical rating scale (NRS) of 0–10 Intramuscularly administering a reduced dose of ketamine in which 0 equaled no pain and 10 was the worst possible at the end of surgery was efective in reducing the incidence pain. Any patient reporting a pain score of 5 or more was of EA in adults who underwent septoplasty or OSRP. given 1 g of intravenous paracetamol. Any patient experi- However, this accompanied a 29-second delay in response to encing PONV was given 4 mg of ondansetron. verbal stimuli. Te pain scores (NRS) were lower for Group K. Te risk factors for agitation included ASA II physical 2.2. Statistics. Te categorical data were presented in fre- status, longer surgical duration, and OSRP surgery. No quency and percentages, and continuous variables were clinically signifcant diferences were noted between study presented as mean± standard deviation. Te chi-square of groups in terms of gender, type of surgery, ASA classif- independence was used to explore the bivariate association cation, age, and BMI (a p value >0.05 for all variables). between the categorical data. To compare continuous var- Te incidence of EA was 56.3%, which is higher than or iables, the independent t test was used alongside the mul- almost similar to that reported by some earlier studies [2, 4] tivariable analysis by the backward binary stepwise logistic that investigated the incidence of EA following nasal surgery. regression model to predict the risk factors for postoperative Tis diference may be attributed to the type of nasal surgery, agitation; any variables signifcant at p≤ 0.20 in the bivariate certain risk factors, or the absence of a specifc scale for analysis were nominated for entry into the regression model evaluating postoperative agitation in each study. Te efcacy and were reported as the odds ratio (OR) with 95% conf- of ketamine in EA prevention after nasal surgery has been ˘ ˘ dence interval (CI). Te Hosmer–Lemeshow test was used to investigated, and Abitagaoglu et al. [13] reported that the express model goodness-of-ft. intravenous administration of ketamine after anesthesia 4 Anesthesiology Research and Practice Table 2: Richmond Agitation-Sedation Scale. Score Term Description +4 Combative Overtly combative or violent; immediate danger to staf +3 Very agitated Pulls on or removes tube(s) or catheter(s) or has aggressive behavior towards staf +2 Agitated Frequent nonpurposeful movement or patient-ventilator dyssynchrony +1 Restless Anxious or apprehensive but movements not aggressive or vigorous 0 Alert and calm Not fully alert, but has sustained (more than 10 seconds) awakening, with eye −1 Drowsy contact, to voice −2 Light sedation Briefy (less than 10 seconds) awakens with eye contact to voice −3 Moderate sedation Any movement (but no eye contact) to voice −4 Deep sedation No response to voice, but any movement to physical stimulation −5 Unarousable No response to voice or physical stimulation Table 3: Bivariate analysis for risk factors of postoperative agitation. Agitation Variables Category Test value p value Nonagitated n (%) Agitated n (%) Saline 35 (43.8) 45 (56.3) Study’s arms 49.45 ≤0.001 Ketamine 76 (95.0) 4 (5.0) Male 56 (65.9) 29 (34.1) Gender 1.041 0.308 Female 55 (73.3) 20 (26.7) Septoplasty 62 (75.6) 20 (24.4) Type of surgery 3.078 0.079 OSRP 49 (62.8) 29 (37.2) I 56 (78.9) 15 (21.1) ASA 5.420 0.020 II 55 (61.8) 34 (38.2) Age (years) Mean± SD 28.92± 8.52 26.02± 6.18 2.145 0.034 BMI Mean± SD 24.01± 2.98 24.12± 2.89 0.223 0.824 Pain score Mean± SD 3.44± 1.73 4.24± 1.56 2.793 0.006 Duration of Surgery (min) Mean± SD 107.03± 46.18 124± 49.37 2.209 0.029 a � chi-square test; b � independent t-test; SD � standard deviation. Tese are the P values of the factors that found to have signifcant association with EA in the bivariate analysis. Table 4: Multivariate binary logistic regression analysis to predict rhinoplasty showed that ketamine reduced the incidence of agitation. EA at subanesthetic doses but prolonged the duration of anesthesia. Adjusted OR Variables B S.E Wald p value In a study on the efect of intramuscular ketamine as (95% CI) a sedative agent on severely agitated patients in the emergency Study’s arms ≤0.001 department, the results were inconclusive as to its dose that 0.033 Ketamine −3.425 0.589 33.860 may produce dissociation, which was already established as 3- (0.010–0.103) 4 mg/kg [14]. Intramuscular ketamine at a dose of <5 mg/kg Saline 1.0 (reference) ASA 0.008 provides adequate sedation with a low risk for intubation [15], 3.286 but a dose of 4 mg/kg was efective in producing sedation for I 1.190 0.450 6.980 (1.359–7.944) severe agitation but with an increased risk of intubation [16]. II 1.0 (reference) Reducing the dose to 2 mg/kg, O’Brien et al. [17] reported that Duration of 1.010 intramuscular ketamine caused adequate sedation and was 0.010 0.005 4.664 0.031 surgery (1.001–1.020) efective for severe agitation without the need for intubation. Type of surgery 0.037 In this study, the smaller 0.7 mg/kg dose signifcantly reduced 2.157 OSRP 0.923 0.443 4.335 the incidence of agitation following septoplasty and OSRP, (1.056–5.999) and caused light sedation (RASS = −2) in 26 patients out of the Septoplasty 1.0 (reference) 80 patients of Group K. Nagelkerke R square � 0.457,; Hosmer Lemesho test (X � 5.411, p � 0.713). Isofurane was used to maintain anesthesia because the literature has related that there is an increased incidence of EA induction did not afect the incidence of EA in adults who to agents with low blood-gas partition coefcients such as underwent septoplasty surgeries and delayed the response to sevofurane and desfurane [4, 18–20]. Pain has been con- verbal stimuli. Demir and Yuzkat [9] reported that the efect sidered an important independent risk factor for EA [4, 21]. of ketamine intravenously administered 20 minutes before Higher doses of intraoperative opioids were associated with the end of surgery on 140 patients who underwent a higher incidence of agitation [20], which is why the Anesthesiology Research and Practice 5 Table 5: Postoperative follow-up data. Groups Variables Test value p value Normal saline Ketamine No 68 (85.0%) 61 (76.3%) PONV 1.960 0.161 Yes 12 (15.0%) 19 (23.8%) No 78 (97.5%) 74 (92.5%) Additional antiemetic requirement 2.105 0.147 Yes 2 (2.5%) 6 (7.5%) Time to verbal response (min) 2.90± 1.03 3.38± 0.92 3.086 0.002 Postoperative pain 4.61± 1.53 2.76± 1.35 8.102 <0.001 a � chi-square test; b � independent t-test; PONV � postoperative nausea and vomiting. Tese are the P values of the factors that found to have clinically signifcant diference in the results between the two arms of the study. [2] D. Yu, W. Chai, X. Sun, and L. Yao, “Emergence agitation in researchers administered a lower dose of morphine. In contrast adults: risk factors in 2,000 patients,” Canadian Journal of to previous research, this study shows that pain is signifcantly Anesthesia/Journal canadien d’anesthesie, vol. 57, no. 9, associated with agitation in bivariate analysis but not a sig- pp. 843–848, 2010. nifcant predictor of EA in multivariant binary logistic [3] S. J. Lee, S. J. Choi, C. B. In, and T. Y. Sung, “Efects of regression. tramadol on emergence agitation after general anesthesia for Research on the EA risk factors after nasal surgery listed the nasal surgery A retrospective cohort study,” Medicine, vol. 98, following factors as risk factors: youth, male gender, post- Article ID 147633, 2019. operative pain, inhalational anesthesia, smoking, PONV, and [4] H. J. Kim, D. K. Kim, H. Y. Kim, J. K. Kim, and S. W. Choi, the presence of a tracheal tube and a urinary catheter. [4, 2], “Risk factors of emergence agitation in adults undergoing [22], [23] Although the male gender was considered a risk general anesthesia for nasal surgery,” Clin Exp Otorhinolar- factor in previous studies, there was no signifcant diference in yngol, vol. 8, no. 1, pp. 46–51, 2015. the incidence of EA between the 85 males and 75 females in this [5] N. Y. Kim, S. Y. Kim, H. J. Yoon, and H. K. Kil, “Efect of study. Te ASA II physical status proved to be a signifcant risk dexmedetomidine on sevofurane requirements and emer- factor for EA which could be attributed to the fact that many gence agitation in children undergoing ambulatory surgery,” patients in this study were smokers. Both the duration and type Yonsei Medical Journal, vol. 55, no. 1, pp. 209–215, 2014. of nasal surgery were found to be signifcant risk factors which [6] F. Veyckemans, Excitation Phenomena during Sevofurane disprove previous research fndings [4]. As the study was Anaesthesia in Children, Lippincott Williams & Wilkins, multicenter, the surgical procedures were performed by dif- Philadelphia, PA, USA, 2001. ferent surgeons which may contribute to the variation in the [7] K. Hudek, “Emergence delirium: a nursing perspective,” duration of the surgery and can be considered a limitation. AORN Journal, vol. 89, no. 3, pp. 509–520, 2009. [8] R. Polat, K. Peker, I. Baran, G. Bumin Aydın, Topçu Gul ¨ oks ¨ uz, ¨ and A. Donmez, ¨ “Vergleich zwischen dexmedetomidin- und 5. Conclusion remifentanilinfusion bei agitation in der aufwachphase nach Intramuscular ketamine is highly efective in preventing EA nasenoperation: eine randomisierte doppelblindstudie,” Der following septoplasty and OSRP when administered at Anaesthesist, vol. 64, no. 10, pp. 740–746, 2015. a dose of 0.7 mg/kg at the end of surgery. Although it is [9] C. Y. Demir and N. Yuzkat, “Prevention of emergence agi- difcult to prevent EA completely, it can be reduced by tation with ketamine in rhinoplasty,” Aesthetic Plastic Surgery, modifying risk factors whenever possible. While in- vol. 42, no. 3, pp. 847–853, 2018. [10] M. A. Gropper and R. D. Miller, Miller’s Anesthesia, Elsiver, tramuscular ketamine was preventive, ASA II physical Amsterdam, Netherlands, 2019. status, longer duration of surgery, and OSRP surgery were [11] F. M. D. Pamela, P. R. M. D. James, D. Richard, and the main risk factors for EA development. M. D. Urman, Stoelting Pharmacology and Physiology, Wol- ters Kluwer, Alphen aan den Rijn, Netherlands, 2021. Data Availability [12] C. N. Sessler, M. S. Gosnell, M. J. Grap et al., “Te Richmond Agitation-Sedation Scale: validity and reliability in adult in- Te data used to support the fndings of this study are in- tensive care unit patients,” American Journal of Respiratory cluded within the article. and Critical Care Medicine, vol. 166, no. 10, pp. 1338–1344, Conflicts of Interest [13] S. Abitagao ˘ glu, ˘ C. Koksal, ¨ S. Alagoz, ¨ C. S¸. Karip, and D. E. Arı, “Efect of ketamine on emergence agitation following sep- Te authors declare that they have no conficts of interest. toplasty: a randomized clinical trial,” Brazilian Journal of Anesthesiology (English Edition), vol. 71, no. 4, pp. 381–386, References [14] S. M. Green, M. G. Roback, R. M. Kennedy, and B. Krauss, [1] C. Lepouse, ´ C. A. Lautner, L. Liu, P. Gomis, and A. Leon, “Clinical practice guideline for emergency department ket- “Emergence delirium in adults in the post-anaesthesia care amine dissociative sedation: 2011 update,” Annals of Emer- unit,” British Journal of Anaesthesia, vol. 96, no. 6, pp. 747– 753, 2006. gency Medicine, vol. 57, no. 5, pp. 449–461, 2011. 6 Anesthesiology Research and Practice [15] B. D. Hayes, “Ketamine for agitation: a key cog in the pre- hospital treatment armamentarium wheelhouse,” Clinical Toxicology, vol. 54, no. 7, pp. 545-546, 2016. [16] S. Bernard, R. Roggenkamp, A. Delorenzo et al., “Use of intramuscular ketamine by paramedics in the management of severely agitated patients,” Emergency Medicine Australasia, vol. 33, no. 5, pp. 875–882, Oct. 2021. [17] M. E. O’Brien, L. Fuh, A. S. Raja, B. A. White, B. J. Yun, and B. D. Hayes, “Reduced-dose intramuscular ketamine for se- vere agitation in an academic emergency department,” Clinical Toxicology, vol. 58, no. 4, pp. 294–298, 2020. [18] A. Kanaya, “Emergence agitation in children: risk factors, prevention, and treatment,” Journal of Anesthesia, vol. 30, no. 2, pp. 261–267, 2016. [19] A. Fields, J. Huang, D. Schroeder, J. Sprung, and T. Weingarten, “Agitation in adults in the post-anaesthesia care unit after general anaesthesia,” British Journal of An- aesthesia, vol. 121, no. 5, pp. 1052–1058, 2018. [20] L. Munk, G. Andersen, and A. M. Møller, “Post-anaesthetic emergence delirium in adults: incidence, predictors and consequences,” Acta Anaesthesiologica Scandinavica, vol. 60, no. 8, pp. 1059–1066, 2016. [21] J. Mizuno, Y. Nakata, S. Morita, H. Arita, and K. Hanaoka, “[Predisposing factors and prevention of emergence agita- tion],” Masui, vol. 60, no. 4, p. 425–435, 2011. [22] J. C. Rim, J. A. Kim, I. Hong, S. Y. Park, J. H. Lee, and C. J. Chung, “Risk factors of emergence agitation after general anesthesia in adult patients,” Anesthesia and Pain Medicine, vol. 11, no. 4, pp. 410–416, 2016. [23] L. Lin, S. Liu, Z. Chen, and S. Lin, “Efect of ketamine combined with butorphanol on emergence agitation of postoperative patients with gastric cancer,” Terapeutics and Clinical Risk Management, vol. 12, pp. 713–717, 2016. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Anesthesiology Research and Practice Hindawi Publishing Corporation

Intramuscular Ketamine Effect on Postnasal Surgery Agitation: A Prospective Double-Blinded Randomized Controlled Trial

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Hindawi Anesthesiology Research and Practice Volume 2023, Article ID 2286451, 6 pages https://doi.org/10.1155/2023/2286451 Research Article Intramuscular Ketamine Effect on Postnasal Surgery Agitation: A Prospective Double-Blinded Randomized Controlled Trial 1 1 1 1 Husam A. Almajali , Ali M. Abu Dalo , Nidal M. Al-Soud , Ali Almajali , 2 1 1 Abdelrazzaq Alrfooh , Thani Alawamreh , and Hamza Al-Wreikat Department of Anaesthesia and Intensive Care, Jordanian Royal Medical Services, Amman, Jordan Department of ENT, Jordanian Royal Medical Services, Amman, Jordan Correspondence should be addressed to Husam A. Almajali; dr.majali1@yahoo.com and Ali M. Abu Dalo; a.ad_91@yahoo.com Received 3 December 2022; Revised 16 February 2023; Accepted 17 February 2023; Published 27 February 2023 Academic Editor: Ronald G. Pearl Copyright © 2023 Husam A. Almajali et al. Tis is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Tis study investigates the efect of intramuscular ketamine on emergence agitation (EA) following septoplasty and open septorhinoplasty (OSRP) when administered at subanesthetic doses at the end of surgery. A random sample of 160 ASA I-II adult patients who underwent septoplasty or OSRP between May and October, 2022, was divided into two groups of eighty patients each: ketamine (Group K) and saline (Group S) with the latter serving as the control group. At the end of surgery immediately after turning of the inhalational agent, Group K was administered with intramuscular 2 ml of normal saline containing 0.7 mg/kg ketamine and Group S with 2 ml of intramuscular normal saline. Sedation and agitation scores at emergence from anesthesia were recorded after extubation using the Richmond Agitation-Sedation Scale (RASS). Te incidence of EA was higher in the saline group than in the ketamine group (56.3% vs. 5%; odds ratio (OR): 0.033; 95% confdence interval (CI): 0.010–0.103; p< 0.001). Variables associated with a higher incidence of agitation were ASA II classifcation (OR: 3.286; 95% (CI): 1.359–7.944; p � 0.008), longer duration of surgery (OR: 1.010; 95% CI: 1.001–1.020; p � 0.031), and OSRP surgery (OR: 2.157; CI: 1.056–5.999; p � 0.037). Te study concluded that the administration of intramuscular ketamine at a dose of 0.7 mg/kg at the end of surgery efectively reduced the incidence of EA in septoplasty and OSRP surgery. ENT surgeries, current smoking, and the presence of a tra- 1. Introduction cheal tube [2, 4]. Dealing with an agitated patient can be challenging. Although EA spontaneously resolves typically after Emergence agitation (henceforth, EA) is a postanesthetic a short period [5], it may lead to serious consequences such phenomenon characterized by restlessness, excitation, and as bleeding, self-extubation, prolonged hospital admission, confusion during early recovery from general anesthesia [1] and injury to the patient and theatre staf [6, 7]. Tus, in around 22.2% of patients[2]. Te precise cause of EA is eliminating risk factors and adequate postoperative pain still unknown, since one retrospective cohort study attrib- control leading to the efective prevention of EA will im- uted EA to the sense of sufocation caused by nasal packing prove clinical outcomes [2]. following surgeries [3], and another claimed the opposite, Studies have investigated diferent drugs and found some i.e., nasal packing did not increase the incidence of EA [4]. to be efective in EA prevention including opioids, alpha 2 Other potential risk factors include ASA (American Society receptor agonists such as dexmedetomidine, and ketamine of Anesthesiologists) physical status ≥2, young age, post- [3, 9, 10]. Ketamine, an N-methyl-D-aspartate (NMDA) operative pain, male gender, inhalational anesthesia, post- receptor antagonist used as an anesthetic agent, has an operative nausea and vomiting (PONV), oral cavity and analgesic efect at subanesthetic doses [10]. Te peak plasma 2 Anesthesiology Research and Practice Enrollment Assessed for eligibility (n= 193) Excluded (n=33) (i) Not meeting inclusion criteria (n=33) (ii) Declined to participate (n=0) (iii) Other reasons (n=0) Randomized (n=160) Allocation Allocated to Group-K (n=80) Allocated to Group-S (n=80) (i) Received allocated intervention (n=80) (i) Received allocated intervention (n=80) (ii) Did not receive allocated intervention (n=0) (iii) Did not receive allocated intervention (n=0) Follow-Up Lost to follow-up (n=0) Lost to follow-up (n=0) Discontinued intervention (n=0) Discontinued intervention (n=0) Analysis Analysed (n=80) Analysed (n=80) (i) Excluded from analysis (n=0) (i) Excluded from analysis (n=0) Figure 1: Consort fow diagram. concentrations of ketamine following IV and IM adminis- patients scheduled for septoplasty or open septorhinoplasty tration occur within 1 to 5 minutes, respectively [11]. To the who were frst assessed for eligibility which resulted in the best of the researchers’ knowledge, the efect of ketamine on exclusion of 33 patients: 17 with a BMI <20 or >30, 8 under EA following nasal surgeries has been investigated only 18 years of age, 4 with a history of hypertension, 3 with when it was intravenously administered. a psychiatric problem, and 1 with morphine allergy. Te 160 Tis study investigates the efect of ketamine on EA patients were randomly distributed into two equal groups: following septoplasty and open septorhinoplasty (henceforth, the ketamine group (Group K) and the saline (Group S) OSRP) when intramuscularly administered at subanesthetic group. Te demographical and clinical data are summarized doses to reduce the incidence of EA. Te researchers resorted in Table 1. to intramuscular ketamine injection to reduce the incidence Random Allocation software was used to provide simple of EA without causing signifcant sedation and without in- random codes for ketamine and normal saline syringes, all of creasing the response time to verbal stimulus, as drug ab- which were prepared and sealed in sequentially coded sorption and the onset of action will be slower than the IV identical opaque containers as per the allocation sequence of route investigated earlier [9]. Te primary outcome of the the specialist physician who partook in the randomization study was developing agitation (RASS≥ 2), and the secondary process and was excluded from the follow-up. Te anesthetic is the numerical rating scale of pain (NRS) ≥5. nurse provided the sequential opaque container just before turning of the inhalational agent, and the researchers 2. Materials and Methods documented the syringe code. Patients, researchers, out- come assessors, and anesthetic nurses were all kept blinded Tis multicenter randomized study, the steps of which are for allocation. given in Figure 1, was performed between May and October, 2022, after it was approved by the Royal Medical Services Human Research Ethics Committee (registration number 2.1. General Anesthesia and Surgical Procedure. Te patients NCT05313659 at https://clinicaltrials.gov). Te sample in- were taken to the operating room without any premed- ication. Standard AAGBI monitors were used. Anesthesia cluded patients aged 18–64 with ASA physical status I-II scheduled for septoplasty and OSRP from whom a written was intravenously induced by 1.5 μg/kg fentanyl, 2 mg/kg propofol, and 0.6 mg/kg rocuronium which was maintained consent was obtained. Patients with ketamine or morphine allergies, a history of cardiac, neurological, or psychiatric through a mixture of 50% oxygen and 1.2% isofurane in the disease, glaucoma, and a body mass index of less than 20 or air at a fow rate of 2.5 L/min. For intraoperative analgesia more than 30 kg/m were excluded. and hypotensive technique, remifentanil infusion at a rate of To achieve the purpose of the study using the GPower 0.05–2 μg/kg/min was used. Following intubation, all pa- computer program, considering alpha set at 0.05 with tients received 8 mg of dexamethasone as prophylaxis for medium efect size, a study power of 80%, and a sample size postoperative nausea and vomiting (henceforth, PONV). of 158 and 79 in each group was deemed suitable. Tus, the Te ventilator parameters were adjusted at a tidal volume of researchers opted for a sample of 160 patients, from the 193 7–10 ml/kg and a respiratory rate of 10–12 breaths/min to Anesthesiology Research and Practice 3 Table 1: Demographical and clinical data of the sample. A p value of <0.05 was considered statistically signif- cant. Statistical analyses were performed using the SPSS for Study’s arms (N � 160) Windows (version 28; IBM Corporation). Variables Category N (%) Ketamine Saline n (%) n (%) 3. Results Male 85 (53.1) 43 (53.8) 42 (52.5) Gender Female 75 (46.9) 37 (46.3) 38 (47.5) As given in Table 3, the bivariate analysis shows that the Septoplasty 82 (51.2) 41 (51.2) 41 (51.2) incidence of EA in the saline group was 56.3% but only 5% in Surgery OSRP 78 (48.8) 39 (48.8) 39 (48.8) the ketamine group (p≤ 0.001). I 71 (44.4) 35 (43.8) 36 (45.0) Te other variables with signifcant diferences between ASA II 89 (55.6) 45 (56.3) 44 (55.0) agitated and nonagitated patients were ASA physical status Age (years) Mean± SD 28± 7.9 27.2± 7.5 28.8± 8 classifcation (p � 0.020), age (p � 0.034), pain score BMI Mean± SD 24± 2.9 24.2± 2.9 23.9± 2.9 (p � 0.006), and duration of surgery (p � 0.029). In addition OSRP � open septorhinoplasty; ASA � American Society of Anesthesiolo- to these fve variables, an extra variable associated with EA gists physical status classifcation; BMI � body mass index. (p≤ 0.2) in the bivariate analysis (the type of surgery) was entered into the multivariate backward binary logistic re- gression model, and the following four variables were found maintain the end-tidal CO2 levels of 30–35 mmHg. Remi- to be signifcantly associated with EA: study arms, ASA fentanil infusion was stopped 10 minutes before the end of physical status classifcation, duration of surgery, and type of the surgery to prevent any delay in the emergence from surgery, as shown in Table 4. Te EA odds were 0.033 times anesthesia. At the end of the surgery immediately after the lower in Group K than in Group S which means that the inhalational agent was discontinued, 2 ml of normal saline incidence of EA has been reduced by 96.7% in Group K. containing 0.7 mg/kg of racemic ketamine was in- On the other hand, the EA odds were 3.3 times higher in tramuscularly administered to Group K, and only 2 ml of ASA II than in ASA I, and 2.2 times higher in OSRP than in normal saline was administered to Group S using a 3 ml septoplasty surgery. Tey were also expected to increase by syringe. Te injection site of both groups was the lateral 1.01 times per minute for the duration of the surgery. thigh. For postoperative analgesia, 0.07 mg/kg of in- Table 5 shows the time taken to obtain a response to travenous morphine was also administered when the in- verbal stimuli after extubation, the incidence of post- halational agent was turned of, and a nasal pack was used for operative pain, PONV, and additional antiemetic re- all patients. Te patients were ventilated with 100% oxygen quirements in the PACU. While the time taken to obtain at a fow rate of 7 l/min and then extubated once they met a verbal response to verbal stimuli was higher in Group K extubation criteria. (p< 0.002) with a mean diference of 0.48 minutes Te patients’ EA level was evaluated using the Richmond (29 seconds), but the postoperative pain score was signif- Agitation-Sedation Scale (RASS) immediately after extu- cantly lower in this group than that of Group S (p< 0.001). bation until they were handed over to the postanesthaesia Tere were no statistically signifcant diferences between the care unit (henceforth, PACU), and the highest score study arms when considering PONV occurrence and ad- documented, is shown in Table 2 (adapted from [12]). For ditional antiemetic requirements in the PACU. the purpose of this study, patients with a RASS score of +2 or more were considered to have EA. During the frst 30 minutes in the PACU, the pain score 4. Discussion was evaluated using the numerical rating scale (NRS) of 0–10 Intramuscularly administering a reduced dose of ketamine in which 0 equaled no pain and 10 was the worst possible at the end of surgery was efective in reducing the incidence pain. Any patient reporting a pain score of 5 or more was of EA in adults who underwent septoplasty or OSRP. given 1 g of intravenous paracetamol. Any patient experi- However, this accompanied a 29-second delay in response to encing PONV was given 4 mg of ondansetron. verbal stimuli. Te pain scores (NRS) were lower for Group K. Te risk factors for agitation included ASA II physical 2.2. Statistics. Te categorical data were presented in fre- status, longer surgical duration, and OSRP surgery. No quency and percentages, and continuous variables were clinically signifcant diferences were noted between study presented as mean± standard deviation. Te chi-square of groups in terms of gender, type of surgery, ASA classif- independence was used to explore the bivariate association cation, age, and BMI (a p value >0.05 for all variables). between the categorical data. To compare continuous var- Te incidence of EA was 56.3%, which is higher than or iables, the independent t test was used alongside the mul- almost similar to that reported by some earlier studies [2, 4] tivariable analysis by the backward binary stepwise logistic that investigated the incidence of EA following nasal surgery. regression model to predict the risk factors for postoperative Tis diference may be attributed to the type of nasal surgery, agitation; any variables signifcant at p≤ 0.20 in the bivariate certain risk factors, or the absence of a specifc scale for analysis were nominated for entry into the regression model evaluating postoperative agitation in each study. Te efcacy and were reported as the odds ratio (OR) with 95% conf- of ketamine in EA prevention after nasal surgery has been ˘ ˘ dence interval (CI). Te Hosmer–Lemeshow test was used to investigated, and Abitagaoglu et al. [13] reported that the express model goodness-of-ft. intravenous administration of ketamine after anesthesia 4 Anesthesiology Research and Practice Table 2: Richmond Agitation-Sedation Scale. Score Term Description +4 Combative Overtly combative or violent; immediate danger to staf +3 Very agitated Pulls on or removes tube(s) or catheter(s) or has aggressive behavior towards staf +2 Agitated Frequent nonpurposeful movement or patient-ventilator dyssynchrony +1 Restless Anxious or apprehensive but movements not aggressive or vigorous 0 Alert and calm Not fully alert, but has sustained (more than 10 seconds) awakening, with eye −1 Drowsy contact, to voice −2 Light sedation Briefy (less than 10 seconds) awakens with eye contact to voice −3 Moderate sedation Any movement (but no eye contact) to voice −4 Deep sedation No response to voice, but any movement to physical stimulation −5 Unarousable No response to voice or physical stimulation Table 3: Bivariate analysis for risk factors of postoperative agitation. Agitation Variables Category Test value p value Nonagitated n (%) Agitated n (%) Saline 35 (43.8) 45 (56.3) Study’s arms 49.45 ≤0.001 Ketamine 76 (95.0) 4 (5.0) Male 56 (65.9) 29 (34.1) Gender 1.041 0.308 Female 55 (73.3) 20 (26.7) Septoplasty 62 (75.6) 20 (24.4) Type of surgery 3.078 0.079 OSRP 49 (62.8) 29 (37.2) I 56 (78.9) 15 (21.1) ASA 5.420 0.020 II 55 (61.8) 34 (38.2) Age (years) Mean± SD 28.92± 8.52 26.02± 6.18 2.145 0.034 BMI Mean± SD 24.01± 2.98 24.12± 2.89 0.223 0.824 Pain score Mean± SD 3.44± 1.73 4.24± 1.56 2.793 0.006 Duration of Surgery (min) Mean± SD 107.03± 46.18 124± 49.37 2.209 0.029 a � chi-square test; b � independent t-test; SD � standard deviation. Tese are the P values of the factors that found to have signifcant association with EA in the bivariate analysis. Table 4: Multivariate binary logistic regression analysis to predict rhinoplasty showed that ketamine reduced the incidence of agitation. EA at subanesthetic doses but prolonged the duration of anesthesia. Adjusted OR Variables B S.E Wald p value In a study on the efect of intramuscular ketamine as (95% CI) a sedative agent on severely agitated patients in the emergency Study’s arms ≤0.001 department, the results were inconclusive as to its dose that 0.033 Ketamine −3.425 0.589 33.860 may produce dissociation, which was already established as 3- (0.010–0.103) 4 mg/kg [14]. Intramuscular ketamine at a dose of <5 mg/kg Saline 1.0 (reference) ASA 0.008 provides adequate sedation with a low risk for intubation [15], 3.286 but a dose of 4 mg/kg was efective in producing sedation for I 1.190 0.450 6.980 (1.359–7.944) severe agitation but with an increased risk of intubation [16]. II 1.0 (reference) Reducing the dose to 2 mg/kg, O’Brien et al. [17] reported that Duration of 1.010 intramuscular ketamine caused adequate sedation and was 0.010 0.005 4.664 0.031 surgery (1.001–1.020) efective for severe agitation without the need for intubation. Type of surgery 0.037 In this study, the smaller 0.7 mg/kg dose signifcantly reduced 2.157 OSRP 0.923 0.443 4.335 the incidence of agitation following septoplasty and OSRP, (1.056–5.999) and caused light sedation (RASS = −2) in 26 patients out of the Septoplasty 1.0 (reference) 80 patients of Group K. Nagelkerke R square � 0.457,; Hosmer Lemesho test (X � 5.411, p � 0.713). Isofurane was used to maintain anesthesia because the literature has related that there is an increased incidence of EA induction did not afect the incidence of EA in adults who to agents with low blood-gas partition coefcients such as underwent septoplasty surgeries and delayed the response to sevofurane and desfurane [4, 18–20]. Pain has been con- verbal stimuli. Demir and Yuzkat [9] reported that the efect sidered an important independent risk factor for EA [4, 21]. of ketamine intravenously administered 20 minutes before Higher doses of intraoperative opioids were associated with the end of surgery on 140 patients who underwent a higher incidence of agitation [20], which is why the Anesthesiology Research and Practice 5 Table 5: Postoperative follow-up data. Groups Variables Test value p value Normal saline Ketamine No 68 (85.0%) 61 (76.3%) PONV 1.960 0.161 Yes 12 (15.0%) 19 (23.8%) No 78 (97.5%) 74 (92.5%) Additional antiemetic requirement 2.105 0.147 Yes 2 (2.5%) 6 (7.5%) Time to verbal response (min) 2.90± 1.03 3.38± 0.92 3.086 0.002 Postoperative pain 4.61± 1.53 2.76± 1.35 8.102 <0.001 a � chi-square test; b � independent t-test; PONV � postoperative nausea and vomiting. Tese are the P values of the factors that found to have clinically signifcant diference in the results between the two arms of the study. [2] D. Yu, W. Chai, X. Sun, and L. Yao, “Emergence agitation in researchers administered a lower dose of morphine. In contrast adults: risk factors in 2,000 patients,” Canadian Journal of to previous research, this study shows that pain is signifcantly Anesthesia/Journal canadien d’anesthesie, vol. 57, no. 9, associated with agitation in bivariate analysis but not a sig- pp. 843–848, 2010. nifcant predictor of EA in multivariant binary logistic [3] S. J. Lee, S. J. Choi, C. B. In, and T. Y. Sung, “Efects of regression. tramadol on emergence agitation after general anesthesia for Research on the EA risk factors after nasal surgery listed the nasal surgery A retrospective cohort study,” Medicine, vol. 98, following factors as risk factors: youth, male gender, post- Article ID 147633, 2019. operative pain, inhalational anesthesia, smoking, PONV, and [4] H. J. Kim, D. K. Kim, H. Y. Kim, J. K. Kim, and S. W. Choi, the presence of a tracheal tube and a urinary catheter. [4, 2], “Risk factors of emergence agitation in adults undergoing [22], [23] Although the male gender was considered a risk general anesthesia for nasal surgery,” Clin Exp Otorhinolar- factor in previous studies, there was no signifcant diference in yngol, vol. 8, no. 1, pp. 46–51, 2015. the incidence of EA between the 85 males and 75 females in this [5] N. Y. Kim, S. Y. Kim, H. J. Yoon, and H. K. Kil, “Efect of study. Te ASA II physical status proved to be a signifcant risk dexmedetomidine on sevofurane requirements and emer- factor for EA which could be attributed to the fact that many gence agitation in children undergoing ambulatory surgery,” patients in this study were smokers. Both the duration and type Yonsei Medical Journal, vol. 55, no. 1, pp. 209–215, 2014. of nasal surgery were found to be signifcant risk factors which [6] F. Veyckemans, Excitation Phenomena during Sevofurane disprove previous research fndings [4]. As the study was Anaesthesia in Children, Lippincott Williams & Wilkins, multicenter, the surgical procedures were performed by dif- Philadelphia, PA, USA, 2001. ferent surgeons which may contribute to the variation in the [7] K. Hudek, “Emergence delirium: a nursing perspective,” duration of the surgery and can be considered a limitation. AORN Journal, vol. 89, no. 3, pp. 509–520, 2009. [8] R. Polat, K. Peker, I. Baran, G. Bumin Aydın, Topçu Gul ¨ oks ¨ uz, ¨ and A. Donmez, ¨ “Vergleich zwischen dexmedetomidin- und 5. Conclusion remifentanilinfusion bei agitation in der aufwachphase nach Intramuscular ketamine is highly efective in preventing EA nasenoperation: eine randomisierte doppelblindstudie,” Der following septoplasty and OSRP when administered at Anaesthesist, vol. 64, no. 10, pp. 740–746, 2015. a dose of 0.7 mg/kg at the end of surgery. Although it is [9] C. Y. Demir and N. Yuzkat, “Prevention of emergence agi- difcult to prevent EA completely, it can be reduced by tation with ketamine in rhinoplasty,” Aesthetic Plastic Surgery, modifying risk factors whenever possible. While in- vol. 42, no. 3, pp. 847–853, 2018. [10] M. A. Gropper and R. D. Miller, Miller’s Anesthesia, Elsiver, tramuscular ketamine was preventive, ASA II physical Amsterdam, Netherlands, 2019. status, longer duration of surgery, and OSRP surgery were [11] F. M. D. Pamela, P. R. M. D. James, D. Richard, and the main risk factors for EA development. M. D. Urman, Stoelting Pharmacology and Physiology, Wol- ters Kluwer, Alphen aan den Rijn, Netherlands, 2021. Data Availability [12] C. N. Sessler, M. S. Gosnell, M. J. 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Published: Feb 27, 2023

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