drugset / Trial / NCT06816173

Effect of Propofol Versus Remimazolam Intravenous Anesthesia on Respiratory Depression

NCT06816173

Phase 4 Not yet recruiting 96 enrolled Second Affiliated Hospital of Wenzhou Medical University
RandomizedParallel-groupQuadruple-blindPrevention

Summary

General anesthesia is the preferred choice for pediatric patients, but the induction of volatile anesthetics via face mask may cause preoperative anxiety and postoperative delirium. Total intravenous anesthesia (TIVA) is more suitable for pediatric patients, as it can effectively alleviate preoperative anxiety, reduce the risk of postoperative delirium and mania, shorten hospital stay, reduce medical burden, and increase parental satisfaction. Propofol, although effective for anesthesia, has drawbacks such as injection pain and respiratory and circulatory suppression. Remimazolam is a novel ultra-short-acting benzodiazepine drug, which has no injection pain, minimal impact on respiration and circulation, and rapid onset and elimination, making it suitable for children. However, research on remimazolam in children is limited. This study aims to compare the effect of propofol and remimazolam intravenous anesthesia combined with regional or caudal block on respiratory depression in preschoolers.

Timeline

Start
2025-02
Primary completion
2026-01
Completion
2026-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 4 mg/kg Intravenous
Subject Propofol Small molecule 12 mg/kg Intravenous
Subject Remimazolam Small molecule 1 mg/kg Intravenous
Subject Remimazolam Small molecule 3 mg/kg Intravenous
Background Fentanyl Other / unclassified 2 ug/kg
Background Fentanyl Other / unclassified 3 ug/kg
Background Remifentanil Small molecule 0.05 ug/kg
Background Remifentanil Small molecule 0.4 ug/kg
Background Ropivacaine Other / unclassified 0.25 % Other
Background Ropivacaine Other / unclassified 0.5 ml Other
Background Ropivacaine Other / unclassified 0.75 ml Other