Status:
NOT_YET_RECRUITING
The Effects of Remimazolam on the Incidence of Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients
Lead Sponsor:
RenJi Hospital
Conditions:
Hypoxia
Hysteroscopy
Eligibility:
FEMALE
20-50 years
Phase:
NA
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 hypoxi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06004843
Start Date
August 1 2023
End Date
April 1 2026
Last Update
August 28 2023
Active Locations (1)
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1
Renji Hospital
Shanghai, Pudong New Area, China