Efficacy and Safety of Ciprofol in Laparoscopic Sleeve Gastrectomy (NCT05522998) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Ciprofol in Laparoscopic Sleeve Gastrectomy
China212 participantsStarted 2023-01-01
Plain-language summary
To evaluate the efficacy and safety of ciprofol for the induction of general anesthesia in obese patients undergoing laparoscopic sleeve gastrectomy. A randomized, parallel, propofol injection positive control study will be conducted to select obese patients who will undergo laparoscopic sleeve gastrectomy in the author's hospital. To evaluate the efficacy and safety, the main observation index, secondary observation indexes, safety evaluation indexes, and the incidence of postoperative adverse reactions will be recorded and compared between the two groups.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 18 \< age ≤ 65, regardless of gender;
* ASA is classified as grade I-III;
* BMI≥35kg/m2
* Obese patients who need laparoscopic sleeve gastrectomy under general anesthesia;
* The subjects voluntarily participated in the trial and signed the informed consent.
Exclusion Criteria:
* Contraindications to general anesthesia;
* Accompanied by infectious heart disease such as myocarditis or endocarditis, septicemia;
* Brain injury, possible intracranial hypertension, cerebral aneurysm, cerebrovascular accident history and central nervous system diseases: mental system diseases (schizophrenia, mania, insanity, etc.) and long-term history of taking psychotropic drugs, or other diseases that hinder the measurement of BIS value;
* Acute heart failure, unstable angina pectoris, myocardial infarction within 6 months before screening, resting ECG heart rate ≤ 50 beats / min, third degree atrioventricular block and other serious arrhythmias, serious heart valve disease, QTc: male ≥ 450ms, female ≥ 470ms;
* Abnormal liver and kidney function (ALT or AST ≥ 2.5 times the upper limit of normal value, TBIL ≥ 1.5 times the upper limit of normal value), abnormal renal function (bun or urea ≥ 1.5 times the upper limit of normal value, cr\> the upper limit of normal value, or dialysis treatment within 28 days before operation), or obvious abnormal coagulation function (pt/ aptt/tt higher than the upper limit of normal value), anemia or thrombocytopenia (HB ≤ 90g/l, PLT ≤ 80 ×…
What they're measuring
1
The rate of successful anesthesia induction
Timeframe: Through study completion, an average of 1 year