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

Not Applicable

Recruiting

• Conditions: Hysteroscopy; Overweight or Obesity; Hypoxia
• Interventions: Drug: remimazolam; Drug: Propofol

• Registration Number: NCT06187896
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-17
• Study First Submitted QC: 2023-12-17
• Study Start: 2024-01-01
• Study First Posted: 2024-01-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-20
• Last Update Posted: 2024-07-23
• Primary Completion: 2026-02
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam	remimazolam	In this group, participants are sedated with remimazolam and remifentanil.
propofol	Propofol	In this group, participants are sedated with propofol and remifentanil.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The incidence of other adverse events	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
The incidence of hypoxia	people will be followed for the duration of hospital stay,an expected average about 2 hours	75%≤ SpO2% \<90% for\<60s
The incidence of sub-clinical respiratory depression	people will be followed for the duration of hospital stay,an expected average about 2 hours	90%≤ SpO2\<95%

Trial Locations

Locations (1)

Diansan Su; 🇨🇳 Shanghai, Shanghai, China