Effects of Remimazolam on Severe Hypoxia During Hysteroscopy in Overweight Patients
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
This study is testing if a new sedative called remimazolam can help prevent severe breathing problems during a procedure for overweight patients compared to a standard sedative.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | Female |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06187896 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of remimazolam on the incidence of severe hypoxia during sedated hysteroscopy procedures in overweight or obese patients. It is a single-center, randomized, single-blind, controlled trial involving 600 participants, divided into two groups receiving either remimazolam or propofol combined with remifentanil for sedation. The study aims to determine if remimazolam can reduce the occurrence of hypoxia compared to propofol in this specific patient population. Participants are selected based on specific inclusion and exclusion criteria related to their health status and BMI.
Who should consider this trial
Good fit: Ideal candidates for this study are overweight or obese patients aged 20 to 50 who are undergoing sedated hysteroscopy for assisted reproduction.
Not a fit: Patients with chronic lung diseases, severe liver or renal dysfunction, or significant mental health disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer sedation practices for overweight or obese patients undergoing hysteroscopy, reducing the risk of severe hypoxia.
How similar studies have performed: Previous studies have indicated that remimazolam may have a lower incidence of hypoxia compared to propofol in similar sedation contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Diansan Su — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: diansan su
- Email: diansansu@yahoo.com
- Phone: +862168383702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.