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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ×…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The rate of successful anesthesia induction

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT05522998

SponsorThe Third People's Hospital of Chengdu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Bariatric Surgery trials