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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
600
in this group,patients are treated with remimazolam and remifentanil for reduced sedation.
in this group,patients are treated with propofol and remifentanil for reduced sedation.
Renji Hospital
Shanghai, Pudong New Area, China
The incidence of hypoxia
75%≤ SpO2% ≤89% for\<60s
Time frame: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
The incidence of sub-clinical respiratory depression
90%≤ SpO2\<95%
Time frame: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
The incidence of severe hypoxia
SpO2\<75% or 75%≤ SpO2≤89% for≥60s
Time frame: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Time frame: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
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