drugset / Trial / NCT07083440

Varied Remimazolam Dosages for Pediatric Endoscopy

NCT07083440

Completed 180 enrolled Children's Hospital of Hebei Province
RandomizedParallel-groupSingle-blindTreatment

Summary

This prospective, randomized, comparative study aims to compare the efficacy and safety of three different doses of remimazolam (0.2 mg/kg, 0.3 mg/kg, and 0.4 mg/kg) combined with sufentanil and propofol for painless gastroscopy in pediatric patients. The study will assess sedation quality, propofol consumption, hemodynamic stability, and adverse event profiles to identify an optimal remimazolam dosing regimen.

Timeline

Start
2023-06-01
Primary completion
2024-05-01
Completion
2024-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 0.5 mg/kg Intravenous
Subject Propofol Small molecule 2 mg/kg Intravenous
Subject Remimazolam Small molecule 0.2 mg/kg Intravenous
Subject Remimazolam Small molecule 0.3 mg/kg Intravenous
Subject Remimazolam Small molecule 0.4 mg/kg Intravenous
Background Sufentanil Other / unclassified 0.1 ug/kg Intravenous