Efficacy and Safety of Ciprofol in Laparoscopic Sleeve Gastrectomy

NCT05522998 | Completed Phase 4

• 1 other identifier: 2022063
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bariatric Surgery

Keywords

Efficacy; Safety; Ciprofol; General anesthesia induction; Laparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

• The rate of successful anesthesia induction

  The criteria for success are to meet the following two requirements at the same time: 1) successful induction (i.e. improved investigator awake / sedation score (MOAA / S) ≤ 1) after the administration of the study drug (at most 2 additional times are allowed); 2) No alternative anesthetics were used.

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Time to LOC

  During anesthesia induction, an average of 10 minutes

• Time to disappearance of eyelash reflex

  During anesthesia induction, an average of 10 minutes

• BIS

  During anesthesia induction, an average of 10 minutes

Study Arms (2)

Ciprofol Group

EXPERIMENTAL

Experimental drug: Ciprofol; Dosage form: injection; Specification: 20ml: 50mg; Frequency and duration: intravenous infusion with micropump, anesthesia induction dose 0.4-0.5mg/kg, Administration for 30s (± 5S)

Drug: Ciprofol

Propofol Group

ACTIVE COMPARATOR

Experimental drug: Propofol; Dosage form: injection; Specification: 20ml: 200mg; Frequency and duration: intravenous infusion with micropump, anesthesia induction dose 2-2.5mg/kg, Administration for 30s (± 5S)

Drug: Propofol

Interventions

Ciprofol DRUG

Ciprofol (0.4-0.5mg/kg) for anesthesia induction

Also known as: Ciprofol Group, Experimental Group

Ciprofol Group

Propofol DRUG

propofol(2-2.5mg/kg) for anesthesia induction

Also known as: Propofol Group, Control Group

Propofol Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \< 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.

You may not qualify if:

• 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 × 109/L)
• 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;
• 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);
• 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);
• The subjects who were judged to have difficulty in respiratory management were rated as grade IV by modified Mahalanobis score;
• Known or suspected allergy or contraindication to various components of the study drug or other benzodiazepines, opioids, propofol, muscle relaxants, etc;
• Pregnant or lactating women or subjects with birth plan within 6 months (including men);
• Those who participated in any clinical trial as subjects within 3 months before enrollment;

Sponsors & Collaborators

• The Third People's Hospital of Chengdu: lead

Study Sites (1)

The Third People's Hospital of Chengdu, Affiliated Hospital of Southwest Jiaotong University

Chengdu, Sichuan, 610031, China

Location

Related Publications (1)

• Chi X, Xu Y, Li Q, Xia K, Fu Q. Efficacy and safety of ciprofol for the induction of general anesthesia in patients with obesity undergoing laparoscopic sleeve gastrectomy: A double-blind randomized, controlled study. PLoS One. 2025 Jul 24;20(7):e0329005. doi: 10.1371/journal.pone.0329005. eCollection 2025.

  PMID: 40705792 DERIVED

MeSH Terms

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Propofol; Control Groups

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Xiaowei Chi, M.D.

  Third People's Hospital of Chengdu, Southwest Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 31, 2022
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)