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

Launched by RENJI HOSPITAL · Dec 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called remimazolam on the risk of severe low oxygen levels (hypoxia) during a procedure called sedated hysteroscopy, which is used for assisted reproduction. This trial is particularly focused on overweight or obese women, as they are more likely to experience hypoxia during the procedure. Researchers will compare the safety and effectiveness of remimazolam with another medication, propofol, to see which one results in fewer cases of severe hypoxia during surgery.

To participate in this trial, women between the ages of 20 and 50 who are undergoing this specific procedure may be eligible if they have a body mass index (BMI) of 23 or higher and are generally healthy (classified as ASA grade I or II). Participants will be randomly assigned to receive either remimazolam or propofol for sedation during the surgery. All patients will be monitored closely throughout the procedure to ensure their safety. If you're interested in learning more or considering participation, it's important to discuss it with your healthcare provider.

Gender

FEMALE

Eligibility criteria

• 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.