Actively Recruiting
The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients
Led by RenJi Hospital · Updated on 2024-09-19
600
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 50 years
- Female patients undergoing sedated hysteroscopy for assisted reproduction
- ASA classification I or II
- Body mass index (BMI) of 23 kg/m² or greater
- Signed informed consent form
You will not qualify if you...
- Blood oxygen saturation (SpO2) less than 95% when breathing room air upon entering the room
- Diagnosed with chronic obstructive pulmonary disease (COPD) or other lung diseases needing long-term or intermittent oxygen therapy
- History of mental or neurological disorders such as depression, severe central nervous system depression, Parkinson's, schizophrenia, epilepsy, Alzheimer's, myasthenia gravis
- Severe liver dysfunction
- Severe kidney failure requiring dialysis before surgery
- Severe heart failure with metabolic equivalent of task (METS) less than 4
- History of drug or alcohol abuse within the last 2 years
- Allergies or contraindications to benzodiazepines, flumazenil, opiates and rescue medications, propofol, eggs, or soy products
- Currently breastfeeding
- Considered unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Diansan Su
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
D
diansan su
CONTACT
Y
yanhua he
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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