drugset / Trial / NCT06187896

The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients

NCT06187896

Recruiting 600 enrolled RenJi Hospital
RandomizedParallel-groupSingle-blindPrevention

Summary

Hypoxia is a common adverse event during sedated hysteroscopy for assisted reproduction, and it is more likely to occur in overweight or obese patients. In sedated gastroscopy, the incidence of hypoxia with remimazolam is lower than that with propofol. The present study is a single-center, randomized, single-blind, controlled clinical trial. Overweight or obese patients undergoing sedated hysteroscopy for diagnosis and treatment, with ASA grade I or II, were selected as subjects and randomly divided into an experimental group and a control group, with 300 subjects in each group. Sedation induction and maintenance are performed using remimazolam or propofol combined with remifentanil, respectively, to compare the incidence of severe hypoxia during surgery between the two groups of patients.

Timeline

Start
2024-01-01
Primary completion
2026-02
Completion
2026-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Propofol Small molecule
Subject Remimazolam Small molecule
Background Remifentanil Small molecule

Indications