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

NCT06187896 | Recruiting

• 1 other identifier: remi-zhoujie
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia; Hysteroscopy; Overweight or Obesity

Keywords

hypoxia; sedated hysteroscopy; remimazolam; propofol

Outcome Measures

Primary Outcomes (1)

• The incidence of severe hypoxia

  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 Outcomes (3)

• The incidence of hypoxia

  people will be followed for the duration of hospital stay,an expected average about 2 hours

• The incidence of sub-clinical respiratory depression

  people will be followed for the duration of hospital stay,an expected average about 2 hours

• The incidence of other adverse events

  people will be followed for the duration of hospital stay,an expected average about 2 hours

Study Arms (2)

Remimazolam

EXPERIMENTAL

In this group, participants are sedated with remimazolam and remifentanil.

Drug: remimazolam

propofol

ACTIVE COMPARATOR

In this group, participants are sedated with propofol and remifentanil.

Drug: Propofol

Interventions

remimazolam DRUG

in this group,patients are treated with remimazolam and remifentanil for reduced sedation.

Remimazolam

Propofol DRUG

in this group,patients are treated with propofol and remifentanil for reduced sedation.

propofol

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• SpO2 \< 95% in patients inhaling air upon entering the room.
• Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute and chronic lung diseases requiring long-term or intermittent oxygen therapy.
• 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.
• Patients with severe liver dysfunction.
• Patients with severe renal insufficiency (requiring dialysis before surgery).
• Severe heart failure (METS \< 4).
• 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).
• Allergies or contraindications to benzodiazepines, flumazenil, opiates and their rescue medications, propofol, eggs, or soy products.
• Breastfeeding women.
• Patients whom investigator believe are unsuitable for participating in this trial.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Diansan Su

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (1)

• He Y, Zhou J, Ding X, Huai X, Lin S, Yu W, Su D. The effects of remimazolam on the incidence of severe hypoxemia during sedated hysteroscopy for assisted reproduction in overweight or obese patients: a randomized controlled clinical trial. Trials. 2025 Aug 26;26(1):309. doi: 10.1186/s13063-025-09054-8.

  PMID: 40859372 DERIVED

MeSH Terms

Conditions

Hypoxia; Overweight; Obesity

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

diansan su

CONTACT

+862168383702; diansansu@yahoo.com

yanhua he

CONTACT

+862168383702; 2339570124@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice chair of the department of anesthesiology

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 3, 2024
• Study Start: January 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)