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Recruiting NCT06187896

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

No phase Interventional Hypoxia Hysteroscopy Overweight or Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: remimazolam, Propofol.
Who it may be relevant to
Registry conditions: Hypoxia, Hysteroscopy, Overweight or Obesity. Basic parameters: 20 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients: a Randomized, Controlled Clinical Trial

Overview

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.

Interventions

  • Drug remimazolam
    in this group,patients are treated with remimazolam and remifentanil for reduced sedation.
  • Drug Propofol
    in this group,patients are treated with propofol and remifentanil for reduced sedation.

Primary outcome measures

  • The incidence of severe hypoxia [Time frame: people will be followed for the duration of hospital stay,an expected average about 2 hours]
Secondary outcome measures (3)
  • The incidence of hypoxia [Time frame: people will be followed for the duration of hospital stay,an expected average about 2 hours]
  • The incidence of sub-clinical respiratory depression [Time frame: people will be followed for the duration of hospital stay,an expected average about 2 hours]
  • The incidence of other adverse events [Time frame: people will be followed for the duration of hospital stay,an expected average about 2 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Diansan Su — Shanghai

Publications

  • 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

Identifiers

NCT: NCT06187896 · remi-zhoujie

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗