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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 50
Healthy Volunteers: f
View:

• Age between 20 and 50 years.

• Patients undergoing sedated hysteroscopy for assisted reproduction.

• ASA classification I-II.

• BMI ≥ 23 kg/㎡.

• Patients who have signed an informed consent form.

Locations
Other Locations
China
Diansan Su
RECRUITING
Shanghai
Contact Information
Primary
diansan su
diansansu@yahoo.com
+862168383702
Backup
yanhua he
2339570124@qq.com
+862168383702
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-04
Participants
Target number of participants: 600
Treatments
Experimental: Remimazolam
In this group, participants are sedated with remimazolam and remifentanil.
Active_comparator: propofol
In this group, participants are sedated with propofol and remifentanil.
Related Therapeutic Areas
Sponsors
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov