NCT06187896 The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients
| NCT ID | NCT06187896 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Hypoxia |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2024-01-01 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06187896 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 50 Years, studying Hypoxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06187896 currently recruiting?
Yes, NCT06187896 is actively recruiting participants. Contact the research team at diansansu@yahoo.com for enrollment information.
Where is the NCT06187896 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06187896 clinical trial?
NCT06187896 is sponsored by RenJi Hospital. The trial plans to enroll 600 participants.