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

September 12, 2024 updated by: diansan su, RenJi Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Diansan Su
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 20 and 50 years.
  2. Patients undergoing sedated hysteroscopy for assisted reproduction.
  3. ASA classification I-II.
  4. BMI ≥ 23 kg/㎡.
  5. Patients who have signed an informed consent form.

Exclusion Criteria:

  1. SpO2 < 95% in patients inhaling air upon entering the room.
  2. Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute and chronic lung diseases requiring long-term or intermittent oxygen therapy.
  3. Patients with a history of mental and neurological disorders: such as depression, severe central nervous system depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis, etc.
  4. Patients with severe liver dysfunction.
  5. Patients with severe renal insufficiency (requiring dialysis before surgery).
  6. Severe heart failure (METS < 4).
  7. History of drug abuse and/or alcohol abuse within the 2 years preceding the screening period (consuming more than three times the standard alcoholic beverages daily, approximately 10g of alcohol, or equivalent to 50g of Chinese alcohol).
  8. Allergies or contraindications to benzodiazepines, flumazenil, opiates and their rescue medications, propofol, eggs, or soy products.
  9. Breastfeeding women.
  10. Patients whom investigator believe are unsuitable for participating in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remimazolam
In this group, participants are sedated with remimazolam and remifentanil.
Drug: remimazolam
in this group,patients are treated with remimazolam and remifentanil for reduced sedation.
Active Comparator: propofol
In this group, participants are sedated with propofol and remifentanil.
Drug: Propofol
in this group,patients are treated with propofol and remifentanil for reduced sedation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of severe hypoxia
Time Frame: people will be followed for the duration of hospital stay,an expected average about 2 hours
SpO2<75% or 75%≤ SpO2<90% for≥60s
people will be followed for the duration of hospital stay,an expected average about 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of hypoxia
Time Frame: people will be followed for the duration of hospital stay,an expected average about 2 hours
75%≤ SpO2% <90% for<60s
people will be followed for the duration of hospital stay,an expected average about 2 hours
The incidence of sub-clinical respiratory depression
Time Frame: people will be followed for the duration of hospital stay,an expected average about 2 hours
90%≤ SpO2<95%
people will be followed for the duration of hospital stay,an expected average about 2 hours
The incidence of other adverse events
Time Frame: people will be followed for the duration of hospital stay,an expected average about 2 hours
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
people will be followed for the duration of hospital stay,an expected average about 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

December 17, 2023

First Submitted That Met QC Criteria

December 17, 2023

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • remi-zhoujie

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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