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Canadian Journal of Anesthesia/Journal canadien d'anesthésie

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19-12-2022 | Opioids | Reports of Original Investigations

Remimazolam dose for successful insertion of a supraglottic airway device with opioids: a dose-determination study using Dixon’s up-and-down method

Authors: Jeayoun Kim, MD, Seungwon Lee, MD, Youyoung Kim, MD, Ji Seon Jeong, MD, PhD

Published in: Canadian Journal of Anesthesia/Journal canadien d'anesthésie | Issue 3/2023

Abstract

Purpose

Remimazolam, an ultra-short-acting benzodiazepine, was recently approved in numerous jurisdictions as an induction drug for general anesthesia. We aimed to determine the doses of remimazolam that would allow placement of a supraglottic airway device (SGD) in 50% and 95% of nonparalyzed patients (ED₅₀ and ED₉₅).

Methods

In this prospective study, 30 American Society of Anesthesiology Physical Status I–II grade female patients scheduled for hysteroscopic surgery were enrolled. Anesthesia was induced with 1 μg·kg⁻¹ of fentanyl and continuous infusion of remimazolam without neuromuscular blockade. An i-gel® SGD was inserted 2.5 min after the start of remimazolam infusion. We used Dixon’s up-and-down method and isotonic regression to determine the ED₅₀ and ED₉₅ of remimazolam for insertion of an SGD.

Results

Twenty-eight patients were included in the final analysis. The ED₅₀ and ED₉₅ of remimazolam required for successful i-gel insertion were 8.8 mg·kg⁻¹·hr⁻¹ (95% confidence interval [CI], 6.3 to 10.6) and 10.7 mg·kg⁻¹·hr⁻¹ (95% CI, 10.6 to 11.7), respectively. A nonfully relaxed jaw was found in 7/13 patients (54%) in the success group and 14/15 patients (93%) in the failure group (difference in proportions, 40%; 95% CI, 7 to 65; P = 0.02). Bucking or other movements during SGD insertion only occurred in the failure group (11/15, 73%).

Conclusion

In 95% of nonparalyzed female patients undergoing hysteroscopy, 10.7 mg·kg⁻¹·hr⁻¹ of remimazolam with 1 μg·kg⁻¹ of fentanyl facilitates i-gel insertion. Remimazolam showed a high incidence of poor jaw relaxation and bucking or other movements during SGD insertion.

Study registration

Clinical Trial Registry of the Republic of Korea (KCT0006527, https://cris.nih.go.kr; registered 1 September 2021; principal investigator: Ji Seon Jeong).

Keam SJ. Remimazolam: first approval. Drugs 2020; 80: 625–33. https://doi.org/10.1007/s40265-020-01299-8CrossRefPubMed

Sneyd JR, Gambus PL, Rigby-Jones AE. Current status of perioperative hypnotics, role of benzodiazepines, and the case for remimazolam: a narrative review. Br J Anaesth 2021; 127: 41–55. https://doi.org/10.1016/j.bja.2021.03.028CrossRefPubMed

Kim KM. Remimazolam: pharmacological characteristics and clinical applications in anesthesiology. Anesth Pain Med 2022; 17: 1–11. https://doi.org/10.17085/apm.21115

Morita K, Takeda J, Sakamoto A, Yamakage M, Suzuki T. Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial. J Anesth 2020; 34: 543–53. https://doi.org/10.1007/s00540-020-02788-6CrossRefPubMed

Shi F, Chen Y, Li H, Zhang Y, Zhao T. Efficacy and safety of remimazolam tosilate versus propofol for general anesthesia in cirrhotic patients undergoing endoscopic variceal ligation. Int J Gen Med 2022; 15: 583–91. https://doi.org/10.2147/ijgm.s345390CrossRefPubMedPubMedCentral

Hirata N, Suzuki T, Morisaki H, Morimatsu H, Sakamoto A. Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in high-risk surgical patients (ASA Class III): results of a multicenter, randomized, double-blind, parallel-group comparative trial. J Anesth 2020; 34: 491–501. https://doi.org/10.1007/s00540-020-02776-wCrossRefPubMed

Tanaka M, Nishikawa T. Propofol requirement for insertion of cuffed oropharyngeal airway versus laryngeal mask airway with and without fentanyl: a dose‐finding study. Br J Anaesth 2003; 90: 14–20.CrossRefPubMed

Cho SA, Sung TY, Cho CK, Jee YS, Kang PS. Optimal propofol dosage for i-gel® insertion in healthy paralyzed patients. Korean J Anesthesiol 2018; 71: 22–9. https://doi.org/10.4097/kjae.2018.71.1.22CrossRefPubMed

Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: a précis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology 2007; 107: 144–52. https://doi.org/10.1097/01.anes.0000267514.42592.2aCrossRefPubMed

10.

Scheller MS, Zornow MH, Saidman LJ. Tracheal intubation without the use of muscle relaxants: a technique using propofol and varying doses of alfentanil. Anesth Analg 1992; 75: 788–93. https://doi.org/10.1213/00000539-199211000-00024CrossRefPubMed

11.

Muzi M, Robinson BJ, Ebert TJ, O'Brien TJ. Induction of anesthesia and tracheal intubation with sevoflurane in adults. Anesthesiology 1996; 85: 536–43. https://doi.org/10.1097/00000542-199609000-00012CrossRefPubMed

12.

Salmasi V, Maheshwari K, Yang D, et al. Relationship between intraoperative hypotension, defined by either reduction from baseline or absolute thresholds, and acute kidney and myocardial injury after noncardiac surgery: a retrospective cohort analysis. Anesthesiology 2017; 126: 47–65. https://doi.org/10.1097/aln.0000000000001432CrossRefPubMed

13.

Lee B, Lee JR, Na S. Targeting smooth emergence: the effect site concentration of remifentanil for preventing cough during emergence during propofol-remifentanil anaesthesia for thyroid surgery. Br J Anaesth 2009; 102: 775–8. https://doi.org/10.1093/bja/aep090CrossRefPubMed

14.

Morris MD. Small-sample confidence limits for parameters under inequality constraints with application to quantal bioassay. Biometrics 1988; 44: 1083–92.CrossRefPubMed

15.

Iasonos A, Ostrovnaya I. Estimating the dose–toxicity curve in completed phase I studies. Stat Med 2011; 30: 2117–29. https://doi.org/10.1002/sim.4206CrossRefPubMedPubMedCentral

16.

Chia YY, Lee SW, Liu K. Propofol causes less postoperative pharyngeal morbidity than thiopental after the use of a laryngeal mask airway. Anesth Analg 2008; 106: 123–6. https://doi.org/10.1213/01.ane.0000297292.84620.2cCrossRefPubMed

17.

Scanlon P, Carey M, Power M, Kirby F. Patient response to laryngeal mask insertion after induction of anaesthesia with propofol or thiopentone. Can J Anesth 1993; 40: 816–8. https://doi.org/10.1007/bf03009250CrossRefPubMed

18.

Ummenhofer WC, Kindler C, Tschalèr G, Hampl KF, Drewe J, Urwyler A. Propofol reduces succinylcholine induced increase of masseter muscle tone. Can J Anesth 1998; 45: 417–23. https://doi.org/10.1007/bf03012576CrossRefPubMed

19.

Erhan E, Ugur G, Gunusen I, Alper I, Ozyar B. Propofol—not thiopental or etomidate—with remifentanil provides adequate intubating conditions in the absence of neuromuscular blockade. Can J Anesth 2003; 50: 108–15. https://doi.org/10.1007/bf03017840CrossRefPubMed

20.

Ramaswamy AH, Shaikh SI. Comparison of dexmedetomidine-propofol versus fentanyl-propofol for insertion of laryngeal mask airway. J Anaesthesiol Clin Pharmacol 2015; 31: 217–20. https://doi.org/10.4103/0970-9185.155152CrossRefPubMedPubMedCentral

21.

Apfel CC, Läärä E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology 1999; 91: 693–700. https://doi.org/10.1097/00000542-199909000-00022CrossRefPubMed

22.

Grant MC, Kim J, Page AJ, Hobson D, Wick E, Wu CL. The effect of intravenous midazolam on postoperative nausea and vomiting: a meta-analysis. Anesth Analg 2016; 122: 656–63. https://doi.org/10.1213/ane.0000000000000941CrossRefPubMed

23.

Ashay NA, Wasim S, Anil TB. Propofol requirement for insertion of I-gel versus laryngeal mask airway: a comparative dose finding study using Dixon's up-and-down method. J Anaesthesiol Clin Pharmacol 2015; 31: 324–8. https://doi.org/10.4103/0970-9185.161666CrossRefPubMedPubMedCentral

24.

Zaballos M, Bastida E, Agustí S, Portas M, Jiménez C, López-Gil M. Effect-site concentration of propofol required for LMA-Supreme™ insertion with and without remifentanil: a randomized controlled trial. BMC Anesthesiol 2015; 15: 131. https://doi.org/10.1186/s12871-015-0115-8CrossRefPubMedPubMedCentral

25.

Park HJ, Lee JR, Kim CS, Kim SD, Kim HS. Remifentanil halves the EC50 of propofol for successful insertion of the laryngeal mask airway and laryngeal tube in pediatric patients. Anesth Analg 2007; 105: 57–61. https://doi.org/10.1213/01.ane.0000266447.23037.e4CrossRefPubMed

26.

Ang S, Cheong KF, Ng TI. Alfentanil co-induction for laryngeal mask insertion. Anaesth Intensive Care 1999; 27: 175–8. https://doi.org/10.1177/0310057x9902700208CrossRefPubMed

27.

Chae D, Kim HC, Song Y, Choi YS, Han DW. Pharmacodynamic analysis of intravenous bolus remimazolam for loss of consciousness in patients undergoing general anaesthesia: a randomised, prospective, double-blind study. Br J Anaesth 2022; 129: 49–57. https://doi.org/10.1016/j.bja.2022.02.040CrossRefPubMed

28.

Liu M, Sun Y, Zhou L, Feng K, Wang T, Feng X. The median effective dose and bispectral index of remimazolam tosilate for anesthesia induction in elderly patients: an up-and-down sequential allocation trial. Clin Interv Aging 2022; 17: 837–43. https://doi.org/10.2147/cia.s364222CrossRefPubMedPubMedCentral

29.

Shafer SL, Varvel JR. Pharmacokinetics, pharmacodynamics, and rational opioid selection. Anesthesiology 1991; 74: 53–63. https://doi.org/10.1097/00000542-199101000-00010CrossRefPubMed

Title: Remimazolam dose for successful insertion of a supraglottic airway device with opioids: a dose-determination study using Dixon’s up-and-down method
Authors: Jeayoun Kim, MD
Seungwon Lee, MD
Youyoung Kim, MD
Ji Seon Jeong, MD, PhD
Publication date: 19-12-2022
Publisher: Springer International Publishing
Keywords: Opioids
Opioids
Postoperative Nausea and Vomiting
Fentanyl
General Anesthesia
Published in: Canadian Journal of Anesthesia/Journal canadien d'anesthésie / Issue 3/2023
Print ISSN: 0832-610X
Electronic ISSN: 1496-8975
DOI: https://doi.org/10.1007/s12630-022-02379-x

At a glance: The STEP trials

Springer Medicine

Remimazolam dose for successful insertion of a supraglottic airway device with opioids: a dose-determination study using Dixon’s up-and-down method

Abstract

Purpose

Methods

Results

Conclusion

Study registration

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Study registration

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