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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypoxia; Overweight or Obesity; Hysteroscopy
• Intervention / Treatment: Drug: remimazolam; Drug: Propofol

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diansan Su, Dr; Phone Number: +862168383702; Email: diansansu@yahoo.com
• Study Contact Backup: Name: yanhua he, B.S; Phone Number: +862168383702; Email: 2339570124@qq.com

Study Locations

• China
  • Pudong New Area
    • Shanghai, Pudong New Area, China
      • RenJi Hospital
      • Contact: yanhua he, B.S; Phone Number: +862168383702; Email: 2339570124@qq.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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 hypoxia	75%≤ SpO2% ≤89% for<60s	Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of sub-clinical respiratory depression	90%≤ SpO2<95%	Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
The incidence of severe hypoxia	SpO2<75% or 75%≤ SpO2≤89% for≥60s	Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
The incidence of other adverse events	Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force	Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: hysteroscopy; hypoxia; propofol; remimazolam; Overweight or Obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms, Respiratory; Overweight; Hypoxia; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: LY2023-115-A

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