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Bariatric SurgeryPhase 4NCT05522998

Efficacy and Safety of Ciprofol in Laparoscopic Sleeve Gastrectomy

A Phase 4 study testing Ciprofol and Propofol in people with Bariatric Surgery, run by The Third People's Hospital of Chengdu at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bariatric Surgery
What is being tested?
Ciprofol and Propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
1 siteChina
Study dates
1 Jan 2023to 30 Jul 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Chengdu, Sichuan, 610031

Other trials in China

About this study

Official title: Efficacy and Safety of Ciprofol for the Induction of General Anesthesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy

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
Being tested
Ciprofol, Propofol
Keywords
Efficacy, Safety, Ciprofol, General anesthesia induction, Laparoscopic sleeve gastrectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CiprofolDrug

    Also called Ciprofol Group, Experimental Group

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

  • PropofolDrug

    Also called Propofol Group, Control Group

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

Study groups in NCT05522998
Study groupRoleWhat they receive
Ciprofol GroupExperimentalExperimental 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)
Receives: Drug: Ciprofol
Propofol GroupActive comparatorExperimental 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)
Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (3)

  1. Time to LOC

    Time from initial administration of study drug to loss of consciousness

    Measured: 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

    Measured: During anesthesia induction, an average of 10 minutes

  3. BIS

    Changes in bispectral index(BIS) values during anesthesia induction

    Measured: During anesthesia induction, an average of 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2022
  2. Study start1 Jan 2023
  3. Primary completion30 Jun 2023
  4. Study completion30 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05522998
Sponsor's protocol ID
2022063
Status last verified
Aug 2024
First submitted
26 Aug 2022
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40705792

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ciprofol and Propofol in people with Bariatric Surgery, run by The Third People's Hospital of Chengdu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of successful anesthesia induction (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05522998, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.

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