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

Study Overview
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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 hypoxia during surgery between the two groups of patients.

Official Title
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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

Conditions
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Hypoxia, Hysteroscopy, Overweight or Obesity

Intervention / Treatment
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* Drug: remimazolam
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypoxia, hysteroscopy, Overweight or Obesity, remimazolam, propofol