drugset / Trial / NCT05357430

The Application of Remazolam in Gastroenteroscopy

NCT05357430

Completed 83 enrolled Yangzhou University
Non-randomizedParallel-groupDouble-blindHealth-services research

Summary

OBJECTIVE: To study the safety, efficacy and clinical significance of remimazolam in the diagnosis and treatment of patients with daytime gastrointestinal endoscopy, calculate the optimal dose, and conduct relevant verification. Provide a safer and more effective anesthesia solution for the growing special population. METHODS:Around 160 patients were selected to receive painless gastroenteroscopy.,they were divided into four groups of D1, D2, R and C. Group D1 and D2(including 60 patients) were used to calculate the ED50 and ED95 of the drug. According to up-and-down method, they were slowly injected 0.3μg/kg of remifentanil in advance, then 0.20mg/kg of remimazolam, and gastroscopy was performed after MOAA/S score ≤3. The next patient would be increased 0.05mg/kg of remimazolam if there is a positive standrd, otherwise it would be decreased 0.05mg/kg. And the study was terminated when seven crossing points occurred. One hundred patients were randomly divided into two groups of R and C.Before administration of remimazolam, remifentanil injection 0.3 μg/kg were given intravenously in two groups, respectively (injection rate was 30 s).Then group R was given the calculated dose of remimazolam, and group C was given propofol 1.5-2mg/kg.The success rate of sedation, changes in vital signs, adverse reactions, and postoperative recovery were recorded in the two groups.

Timeline

Start
2022-03-01
Primary completion
2023-04-01
Completion
2023-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 1.5 mg/kg
Subject Propofol Small molecule 2 mg/kg
Subject Remimazolam Small molecule 0.2 mg/kg

Indications

No indication recorded.