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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06004843
Other study ID # LY2023-115-A
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2023
Est. completion date April 2026

Study information

Verified date August 2023
Source RenJi Hospital
Contact diansan su, Dr
Phone +862168383702
Email diansansu@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 hypoxia during surgery between the two groups of patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date April 2026
Est. primary completion date February 2026
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
remimazolam
in this group,patients are treated with remimazolam and remifentanil for reduced sedation.
Propofol
in this group,patients are treated with propofol and remifentanil for reduced sedation.

Locations

Country Name City State
China Renji Hospital Shanghai Pudong New Area

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of hypoxia 75%= SpO2% =89% for<60s Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
Secondary The incidence of sub-clinical respiratory depression 90%= SpO2<95% Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
Secondary The incidence of severe hypoxia SpO2<75% or 75%= SpO2=89% for=60s Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
Secondary The incidence of other adverse events Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
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