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

Hypoxia Clinical Trial

— EROP  

Official title:

The Effects of Remimazolam on the Incidence of Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients: a Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06004843
• Other study ID #: LY2023-115-A
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hypoxia
• Hysteroscopy
• Overweight
• Overweight or Obesity

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.