The Efficacy and Safety of Remimazolam Tosilate versus Etomidate-Propofol in Elderly Outpatients Undergoing Colonoscopy: A Prospective, Randomized, Single-Blind, Non-Inferiority Trial

References

• NagataN, IshiiN, ManabeN, et al. Guidelines for colonic diverticular bleeding and colonic diverticulitis: Japan Gastroenterological Association. Digestion. 2019;99(Suppl 1):1–26. doi:10.1159/00049528230625484
   PubMed Web of Science ®Google Scholar
• WatanabeJ, IkegamiY, TsudaA, et al. Lidocaine spray versus viscous lidocaine solution for pharyngeal local anesthesia in upper gastrointestinal endoscopy: systematic review and meta-analysis. Dig Endosc. 2021;33(4):538–548. doi:10.1111/den.1377532573016
   PubMed Web of Science ®Google Scholar
• ChungJW, KimN, WeeJH, et al. Clinical features of snoring patients during sedative endoscopy. Korean J Intern Med. 2019;34(2):305–314. doi:10.3904/kjim.2017.11029132198
   PubMed Web of Science ®Google Scholar
• KimDK. Nonoperating room anaesthesia for elderly patients. Curr Opin Anaesthesiol. 2020;33(4):589–593. doi:10.1097/ACO.000000000000088332618686
   PubMed Web of Science ®Google Scholar
• LaoveeravatP, ThavaraputtaS, SuchartlikitwongS, et al. Optimal sequences of same-visit bidirectional endoscopy: systematic review and meta-analysis. Dig Endosc. 2020;32(5):706–714. doi:10.1111/den.1350331368170
   PubMed Web of Science ®Google Scholar
• DossaF, MegettoO, YakubuM, et al. Sedation practices for routine gastrointestinal endoscopy: a systematic review of recommendations. BMC Gastroenterol. 2021;21(1):22. doi:10.1186/s12876-020-01561-z33413147
   PubMed Web of Science ®Google Scholar
• LeeJG, YooKS, ByunYJ. Continuous infusion versus intermittent bolus injection of propofol during endoscopic retrograde cholangiopancreatography. Korean J Intern Med. 2020;35(6):1338–1345. doi:10.3904/kjim.2018.23332126750
   PubMed Web of Science ®Google Scholar
• SmithI, DurkinD, LauKW, et al. Establishing an anaesthetist-delivered propofol sedation service for advanced endoscopic procedures: implementing the RCA/BSG guidelines. Frontline Gastroenterol. 2018;9(3):185–191. doi:10.1136/flgastro-2017-10083930046422
   PubMed Web of Science ®Google Scholar
• KimMG, ParkSW, KimJH, et al. Etomidate versus propofol sedation for complex upper endoscopic procedures: a prospective double-blinded randomized controlled trial. Gastrointest Endosc. 2017;86(3):452–461. doi:10.1016/j.gie.2017.02.03328284883
   PubMed Web of Science ®Google Scholar
• DoenickeA, LorenzW, HoerneckeR, et al. Histamine release after injection of benzodiazepines and of etomidate. A problem associated with the solvent propylene glycol. Ann Fr Anesth Reanim. 1993;12(2):166–168. doi:10.1016/S0750-7658(05)81025-17690203
   PubMedGoogle Scholar
• KimJ, ChoiSM, ParkYS, et al. Dexmedetomidine versus midazolam for sedation during endobronchial ultrasound-guided transbronchial needle aspiration: a randomised controlled trial. Eur J Anaesthesiol. 2021;38(5):534–540. doi:10.1097/EJA.000000000000137033122573
   PubMed Web of Science ®Google Scholar
• LiWX, LuoRY, ChenC, et al. Effects of propofol, dexmedetomidine, and midazolam on postoperative cognitive dysfunction in elderly patients: a randomized controlled preliminary trial. Chin Med J. 2019;132(4):437–445. doi:10.1097/CM9.000000000000009830707179
   PubMed Web of Science ®Google Scholar
• LeeJM, MinG, LeeJM, et al. Efficacy and safety of etomidate-midazolam for screening colonoscopy in the elderly: a prospective double-blinded randomized controlled study. Medicine. 2018;97(20):e10635. doi:10.1097/MD.000000000001063529768328
   PubMed Web of Science ®Google Scholar
• ChenSH, YuanTM, ZhangJ, et al. Remimazolam tosilate in upper gastrointestinal endoscopy: a multicenter, randomized, non-inferiority, Phase III trial. J Gastroenterol Hepatol. 2021;36(2):474–481. doi:10.1111/jgh.1518832677707
   PubMed Web of Science ®Google Scholar
• SneydJR, GambusPL, Rigby-JonesAE, et al. Current status of perioperative hypnotics, role of benzodiazepines, and the case for remimazolam: a narrative review. Br J Anaesth. 2021;127(1):41–55. doi:10.1016/j.bja.2021.03.02833965206
   PubMed Web of Science ®Google Scholar
• KeamSJ. Remimazolam: first Approval. Drugs. 2020;80(6):625–633. doi:10.1007/s40265-020-01299-832274703
   PubMed Web of Science ®Google Scholar
• HernandezPV, Horsley-SilvaJL, SnyderDL, et al. Effect of bowel preparation volume in inpatient colonoscopy. Results of a prospective, randomized, comparative pilot study. BMC Gastroenterol. 2020;20(1):227. doi:10.1186/s12876-020-01373-132660521
   PubMed Web of Science ®Google Scholar
• CohenLB, DeleggeMH, AisenbergJ, et al. AGA Institute review of endoscopic sedation. Gastroenterology. 2007;133(2):675–701. doi:10.1053/j.gastro.2007.06.00217681185
   PubMed Web of Science ®Google Scholar
• ChandranS, ParkerF, VaughanR, et al. The current practice standard for colonoscopy in Australia. Gastrointest Endosc. 2014;79(3):473–479. doi:10.1016/j.gie.2013.10.05024332081
   PubMed Web of Science ®Google Scholar
• BaschE, BeckerC, RogakLJ, et al. Composite grading algorithm for the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Clin Trials. 2021;18(1):104–114. doi:10.1177/174077452097512033258687
   PubMed Web of Science ®Google Scholar
• Causada-CaloN, BishayK, AlbashirS, et al. Association between age and complications after outpatient colonoscopy. JAMA Netw Open. 2020;3(6):e208958. doi:10.1001/jamanetworkopen.2020.895832584409
   PubMed Web of Science ®Google Scholar
• SeleemWM, El HossienyKM, Abd-ElsalamS. Evaluation of different sedatives for colonoscopy. Curr Drug Saf. 2020;15(1):20–24. doi:10.2174/157488631466619072615423831362661
   PubMed Web of Science ®Google Scholar
• ChenW, ChenS, HuangY. Induction and maintenance of procedural sedation in adults: focus on remimazolam injection. Expert Rev Clin Pharmacol. 2021;14(4):411–426. doi:10.1080/17512433.2021.190157533686920
   PubMed Web of Science ®Google Scholar
• CornettEM, NovitchMB, BrunkAJ, et al. New benzodiazepines for sedation. Best Pract Res Clin Anaesthesiol. 2018;32(2):149–164. doi:10.1016/j.bpa.2018.06.00730322456
   PubMed Web of Science ®Google Scholar
• JiaZ, RenLX, FanYT, et al. Observation of effective dosage of remimazolam tosilate used for moderate-to-deep sedation in fiberoptic bronchoscopy. Zhonghua Yi Xue Za Zhi. 2021;101(11):813–816. doi:10.3760/cma.j.cn112137-20200901-0252433765724
   PubMedGoogle Scholar
• StöhrT, ColinPJ, OssigJ, et al. Pharmacokinetic properties of remimazolam in subjects with hepatic or renal impairment. Br J Anaesth. 2021;127(3):415–423. doi:10.1016/j.bja.2021.05.02734246461
   PubMed Web of Science ®Google Scholar
• KopsMS, PesicM, PetersenKU, et al. Impact of concurrent remifentanil on the sedative effects of remimazolam, midazolam and propofol in cynomolgus monkeys. Eur J Pharmacol. 2021;890:173639. doi:10.1016/j.ejphar.2020.17363933065095
   PubMed Web of Science ®Google Scholar
• AhmadiA, AmriP, ShokriJ, et al. Comparison of the analgesic effect of intravenous paracetamol/midazolam and fentanyl in preparation of patients for colonoscopy: a double blind randomized clinical trial. Caspian J Intern Med. 2015;6(2):87–92.26221506
   PubMedGoogle Scholar
• BorkettKM, RiffDS, SchwartzHI, et al. A phase IIa, randomized, double-blind study of remimazolam (CNS 7056) versus midazolam for sedation in upper gastrointestinal endoscopy. Anesth Analg. 2015;120(4):771–780. doi:10.1213/ANE.000000000000054825502841
   PubMed Web of Science ®Google Scholar
• PambiancoDJ, BorkettKM, RiffDS, et al. A phase IIb study comparing the safety and efficacy of remimazolam and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2016;83(5):984–992. doi:10.1016/j.gie.2015.08.06226363333
   PubMed Web of Science ®Google Scholar
• DoiM, HirataN, SuzukiT, et al. 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(4):491–501. doi:10.1007/s00540-020-02776-w32303884
   PubMed Web of Science ®Google Scholar
• ShimizuH, HommaY, NoriiT, et al. Incidence of adverse events among elderly vs non-elderly patients during procedural sedation and analgesia with propofol. Am J Emerg Med. 2021;44:411–414. doi:10.1016/j.ajem.2020.04.09432409101
   PubMed Web of Science ®Google Scholar
• RexDK, BhandariR, DestaT, et al. A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2018;88(3):427–437.e6. doi:10.1016/j.gie.2018.04.235129723512
   PubMed Web of Science ®Google Scholar
• HanSJ, LeeTH, YangJK, et al. Etomidate sedation for advanced endoscopic procedures. Dig Dis Sci. 2019;64(1):144–151. doi:10.1007/s10620-018-5220-330054843
   PubMed Web of Science ®Google Scholar
• HaoL, HuX, ZhuB, et al. Clinical observation of the combined use of propofol and etomidate in painless gastroscopy. Medicine. 2020;99(45):e23061. doi:10.1097/MD.000000000002306133157963
   PubMed Web of Science ®Google Scholar
• QureshiWA, ZuckermanMJ, AdlerDG, et al. ASGE guideline: modifications in endoscopic practice for the elderly. Gastrointest Endosc. 2006;63(4):566–569. doi:10.1016/j.gie.2006.02.00116564853
   PubMed Web of Science ®Google Scholar
• BowerAL, RipepiA, DilgerJ, et al. Bispectral index monitoring of sedation during endoscopy. Gastrointest Endosc. 2000;52(2):192–196. doi:10.1067/mge.2000.10728410922090
   PubMed Web of Science ®Google Scholar
• TokluS, IyilikciL, GonenC, et al. Comparison of etomidate–remifentanil and propofol– remifentanil sedation in patients scheduled for colonoscopy. Eur J Anaesthesiol. 2009;26(5):370–376. doi:10.1097/EJA.0b013e328318c66619300267
   PubMed Web of Science ®Google Scholar
• SchüttlerJ, EisenriedA, LerchM, et al. Pharmacokinetics and pharmacodynamics of remimazolam (CNS 7056) after continuous infusion in healthy male volunteers: part I pharmacokinetics and clinical pharmacodynamics . Anesthesiology. 2020;132(4):636–651.31972655
   PubMed Web of Science ®Google Scholar
• YamamotoT, KurabeM, KamiyaY. A mechanism of re-sedation caused by remimazolam. J Anesth. 2021;35(3):467–468. doi:10.1007/s00540-021-02930-y33822281
   PubMed Web of Science ®Google Scholar
• WorthingtonMT, AntonikLJ, GoldwaterDR, et al. A phase Ib, dose-finding study of multiple doses of remimazolam (CNS 7056) in volunteers undergoing colonoscopy. Anesth Analg. 2013;117(5):1093–1100. doi:10.1213/ANE.0b013e3182a705ae24108261
   PubMed Web of Science ®Google Scholar
• DuX, ZhouC, PanL, et al. Effect of dexmedetomidine in preventing etomidate-induced myoclonus: a meta-analysis. Drug Des Devel Ther. 2017;11:365–370. doi:10.2147/DDDT.S121979
   PubMed Web of Science ®Google Scholar
• St PierreM, DunkelM, RutherfordA, et al. Does etomidate increase postoperative nausea? A double-blind controlled comparison of etomidate in lipid emulsion with propofol for balanced anaesthesia. Eur J Anaesthesiol. 2000;17(10):634–641. doi:10.1097/00003643-200010000-0000711050522
   PubMed Web of Science ®Google Scholar
• ZhouX, LiBX, ChenLM, et al. Etomidate plus propofol versus propofol alone for sedation during gastroscopy: a randomized prospective clinical trial. Surg Endosc. 2016;30(11):5108–5116. doi:10.1007/s00464-016-4861-627005294
   PubMed Web of Science ®Google Scholar