Remimazolam tosilate in upper gastrointestinal endoscopy: A multicenter, randomized, non-inferiority, phase III trial.

Journal of Gastroenterology and Hepatology
Shao-Hui ChenYu-Guang Huang

Abstract

Remimazolam tosilate (RT) is a new short-acting GABA(A) receptor agonist, having potential to be an effective option for procedural sedation. Here, we aimed to compare the efficacy and safety of RT with propofol in patients undergoing upper gastrointestinal endoscopy. This positive-controlled, non-inferiority, phase III trial recruited patients at 17 centers, between September 2017 and November 2017. A total of 384 patients scheduled to undergo upper gastrointestinal endoscopy were randomly assigned to receive RT or propofol. Primary endpoint was the success rate of sedation. Adverse events (AEs) were recorded to evaluate safety. The success rate of sedation in the RT group was non-inferior to that in the propofol group (97.34% vs 100.00%; difference in rate -2.66%, 95% CI -4.96 to -0.36, meeting criteria for non-inferiority). Patients in the RT group had longer time to adequate sedation (P < 0.0001) but shorter time to fully alert (P < 0.0001) than that in the propofol group. The incidences of hypotension (13.04% vs 42.86%, P < 0.0001), treatment-related hypotension (0.54% vs 5.82%, P < 0.0001), and respiratory depression (1.09% vs 6.88%, P = 0.0064) were significantly lower in the RT group. AEs were reported in 74 (39.15%) pa...Continue Reading

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Citations

May 1, 2021·Journal of Clinical Medicine·Basavana Goudra, Keira P Mason
Mar 10, 2021·Expert Review of Clinical Pharmacology·Weiyun ChenYuguang Huang
Jun 8, 2021·Journal of Oral Science·Shunichi OkaRyutaro Kobayashi
Jun 26, 2021·Digestive Diseases and Sciences·Brian M FungJames H Tabibian
Aug 7, 2021·Frontiers in Pharmacology·Gavin J Kilpatrick
Jul 16, 2021·Minerva anestesiologica·Guangrong DaiXiaobao Zhang

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