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NCT Number: NCT06187896

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

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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Key information

Conditions

Hypoxia Body Weight Hysteroscopy Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight or Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Diansan Su

Shanghai, Shanghai Municipality, 200127, China

Location status: Recruiting

Location contact

diansan su, Dr.

CONTACT

[email protected]

+862168383702

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remimazolam

Drug

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

Propofol

Drug

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

Primary outcomes

  1. The incidence of severe hypoxia

    Time frame: 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 outcomes

  1. The incidence of hypoxia

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

    75%≤ SpO2% <90% for<60s

  2. 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

    90%≤ SpO2<95%

  3. The incidence of other adverse events

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

diansan su

CONTACT

[email protected]

+862168383702

yanhua he

CONTACT

[email protected]

+862168383702

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study 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

Acronym: RP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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