Efficacy and Safety of Ciprofol in Laparoscopic Sleeve Gastrectomy

Korábbi kezelés

• Those who participated in any clinical trial as subjects within 3 months before enrollment;

Más betegség

• 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;
• Have a history of drug abuse and alcoholism within 2 years before the screening period. Alcoholism is defined as regular drinking for more than 14 times / week (once =150 ml wine or 360 ml beer or 45 ml spirits);
• Known or suspected allergy or contraindication to various components of the study drug or other benzodiazepines, opioids, propofol, muscle relaxants, etc;

Laborértékek

• 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 × 109/L)
• Diabetes subjects whose blood glucose was not satisfactorily controlled (fasting blood glucose ≥ 11.1mmol/l in the screening period and / or random blood glucose ≥ 13.6 mmol/l);

Egyéb

• Contraindications to general anesthesia;
• Those whose blood pressure was not satisfactorily controlled (SBP ≥ 160mmhg and / or DBP ≥ 100 mmHg in sitting position during screening period);
• SBP in sitting position during screening period ≤ 90mmHg;
• The subjects who were judged to have difficulty in respiratory management were rated as grade IV by modified Mahalanobis score;
• Pregnant or lactating women or subjects with birth plan within 6 months (including men);
• Other circumstances determined by the researcher as unsuitable for inclusion.

• 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.