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CompletedNCT05522998Updated Aug 28, 2024

Efficacy and Safety of Ciprofol in Laparoscopic Sleeve Gastrectomy

A Phase 4 interventional study of Ciprofol and Propofol in Bariatric Surgery, sponsored by The Third People's Hospital of Chengdu. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-28.

Sponsored by The Third People's Hospital of Chengdu · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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 following indexes will be recorded and compared between the two groups.

  • The main observation index:(1) The rate of successful anesthesia induction
  • Secondary observation indexex:(1) Time from initial administration of study drug to loss of consciousness; (2) Time from initial administration of study drug to disappearance of eyelash reflex; (3) Changes in bispectral index(BIS) values during anesthesia induction
  • Safety evaluation indexes:(1) Adverse events; (2) Intubation response rate; (3) Vital signs; (4) Evaluation of injection pain
  • Adverse events to be focused on:(1)The incidence of blood pressure reduction requiring treatment during anesthesia induction; (2) The incidence of respiratory depression
02

Conditions studied

  • Bariatric Surgery

Keywords

  • Efficacy
  • Safety
  • Ciprofol
  • General anesthesia induction
  • Laparoscopic sleeve gastrectomy
03

In context

Lead sponsor

The Third People's Hospital of Chengdu is the lead sponsor of 12 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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 × 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;
  • Other circumstances determined by the researcher as unsuitable for inclusion.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
212 participants (actual)

Study arms

  • Experimental
    Ciprofol Group

    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

  • Active comparator
    Propofol Group

    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

  • DrugCiprofol

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

    Also known as: Ciprofol Group, Experimental Group

  • DrugPropofol

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

    Also known as: Propofol Group, Control Group

06

What researchers measure

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.

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Time to LOC

    Time from initial administration of study drug to loss of consciousness

    Time frame: During anesthesia induction, an average of 10 minutes

  2. Time to disappearance of eyelash reflex

    Time from initial administration of study drug to disappearance of eyelash reflex

    Time frame: During anesthesia induction, an average of 10 minutes

  3. BIS

    Changes in bispectral index(BIS) values during anesthesia induction

    Time frame: During anesthesia induction, an average of 10 minutes

07

Study locations

1 site
  • The Third People's Hospital of Chengdu, Affiliated Hospital of Southwest Jiaotong University
    Chengdu, Sichuan 610031, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05522998
Lead sponsor
The Third People's Hospital of Chengdu
Responsible party
Xiaowei Chi (Principal Investigator, The Third People's Hospital of Chengdu) — Principal investigator
First posted
Aug 31, 2022
Start date
Jan 1, 2023
Primary completion
Jun 30, 2023
Completion
Jul 30, 2024
Last update
Aug 28, 2024

Study contacts

Xiaowei Chi, M.D.
principal investigator · Third People's Hospital of Chengdu, Southwest Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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