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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypoxia Hysteroscopy Overweight or Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Remimazolam

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

Group Type EXPERIMENTAL

remimazolam

Intervention Type DRUG

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

propofol

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Interventions

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remimazolam

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No