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

Launched by RENJI HOSPITAL · Aug 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called remimazolam during a procedure called sedated hysteroscopy, which is used for assisted reproduction. The focus is on how well remimazolam prevents a problem known as hypoxia, which is when the body doesn't get enough oxygen. Hypoxia can be more common in overweight or obese patients during this procedure. The study will involve 600 women aged 20 to 50 who are overweight or obese and are scheduled to have a sedated hysteroscopy. They will be randomly divided into two groups: one will receive remimazolam and the other will receive a different medication called propofol, along with a pain reliever, to see which combination works better in preventing hypoxia.

To be eligible for this study, participants need to be between 20 and 50 years old, have a body mass index (BMI) of 23 or higher, and be in generally good health (classified as ASA grade I or II). Women who have certain health conditions, such as lung diseases or severe mental health issues, or those who are breastfeeding, will not be able to participate. If someone is eligible and decides to join, they will be closely monitored during the procedure to ensure their safety and to see how well the medications work. It's important for participants to understand what to expect and that their well-being is a top priority throughout the trial.

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.