About this trial
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
This trial does not accept healthy volunteersQualifiers
Age between 20 and 50 years.
Patients undergoing sedated hysteroscopy for assisted reproduction.
ASA classification I-II.
BMI ≥ 23 kg/㎡.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
remimazolam
Drugin this group,patients are treated with remimazolam and remifentanil for reduced sedation.
Propofol
Drugin this group,patients are treated with propofol and remifentanil for reduced sedation.
Treatment groups
Trial outcomes
Primary outcomes
The incidence of severe hypoxia
SpO2\<75% or 75%≤ SpO2\<90% for≥60s
Secondary outcomes
The incidence of hypoxia
75%≤ SpO2% \<90% for\<60s
The incidence of sub-clinical respiratory depression
90%≤ SpO2\<95%
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Sponsors and contacts
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