NCT06004843

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

The Effects of Remimazolam on the Incidence of Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients: a Randomized, Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

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 hypoxia during surgery between the two groups of patients.

Conditions

• Hypoxia
• Hysteroscopy
• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	remimazolam	in this group,patients are treated with remimazolam and remifentanil for reduced sedation.
DRUG	Propofol	in this group,patients are treated with propofol and remifentanil for reduced sedation.

Timeline

• Start date: 2023-08-01
• Primary completion: 2026-02-01
• Completion: 2026-04-01
• First posted: 2023-08-22
• Last updated: 2023-08-28

Locations

1 site across 1 country: China