Drug Design, Development and Therapy (Nov 2021)
The Efficacy and Safety of Remimazolam Tosilate versus Etomidate-Propofol in Elderly Outpatients Undergoing Colonoscopy: A Prospective, Randomized, Single-Blind, Non-Inferiority Trial
Abstract
Xianwen Liu,1 Baofeng Ding,2 Fu Shi,1 Yang Zhang,1 Lei Liu,1 Yongwei Sha,3 Tonghang Zhao1 1Department of Anaesthesiology, Liaocheng People’s Hospital, Liaocheng, Shandong, People’s Republic of China; 2Department of Anaesthesiology, Liaocheng Second People’s Hospital, Liaocheng, Shandong, People’s Republic of China; 3Department of Anaesthesiology, Guanxian Central Hospital, Liaocheng, Shandong, People’s Republic of ChinaCorrespondence: Tonghang Zhao Email [email protected]: The optimal sedation regime during endoscopy remains controversial, especially for elderly outpatients. In this study, we compared the efficacy and safety between remimazolam tosilate (RT) and etomidate-propofol (EP) in elderly outpatients undergoing colonoscopy.Methods: A total of 260 elderly outpatients undergoing sedative colonoscopy were randomized into two groups. Patients in the RT group received a 0.075-mg/kg maintenance dose of remimazolam following an initial dose of 0.15 mg/kg, whereas patients in the EP group (10 mL:20 mg etomidate plus 10 mL:100 mg propofol) received a 0.05-mL/kg maintenance dose following an initial dose of 0.1 mL/kg to maintain a Modified Observer’s Assessment of Alertness/Sedation score of ≤ 3 during the procedure. The primary endpoint was the success of the procedure. Secondary endpoints included time metrics, hemodynamics, consumption of fentanyl, etomidate, propofol, and remimazolam, intraoperative body movement, patient and endoscopist satisfaction scores, supplemental dose of sedative and fentanyl, and incidence and severity of adverse events.Results: The procedure success rate was 96.52% in the RT group and 100% in the EP group. The difference in procedure success rate between the RT and EP groups was − 3.48% (95% confidence interval: − 6.81%, − 0.15%). Four patients in the RT group required rescue midazolam. Compared with patients in the RT group, the onset time of the EP group was significantly lower (p 0.05). Muscular tremor and pain on injection were recorded more frequently in the EP group (p < 0.05). However, there were no significant differences in hypoxia, respiratory depression, or incidence of postoperative nausea and vomiting. The severity of adverse events was all mild (grade 1) across both groups.Conclusion: RT may have non-inferior efficacy and a higher safety profile than EP in elderly outpatients undergoing colonoscopy, which suggests that RT may be more suitable for elderly outpatients undergoing colonoscopy.Keywords: remimazolam tosilate, etomidate, propofol, elderly outpatients, colonoscopy
