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RecruitingNCT06312345Updated Mar 15, 2024

Ciprofol Versus Propofol for Anesthesia Induction in Cardiac Surgery: A Randomized Double-blind Controlled Clinical Trial

An interventional study of Drug: ciprofol injection in Anesthesia, sponsored by Le Yu. Recruiting at 1 site in China. Open to participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Le Yu · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
55 Years to 75 Years
Sex
All
01

Study summary

Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. However, clinical research regarding ciprofol's use for anesthesia induction in cardiac surgery remains limited.

02

Conditions studied

  • Anesthesia
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In context

Lead sponsor

Le Yu is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Elective surgery patients
  2. Aged 55 to 75
  3. New York Heart Association class II or III cardiac functions
  4. Median sternotomy approach for coronary artery bypass grafting or heart valve replacement procedures

Exclusion criteria

Exclusion Criteria:

  1. With a history of benzodiazepine allergy
  2. Significant liver or kidney insufficiency
  3. Coagulation dysfunction
  4. Neurological or psychiatric disorders
  5. Undergone major surgery within the past three months.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Experimental: ciprofol

    Drug: Drug: ciprofol injection

  • Placebo comparator
    Placebo Comparator: propofol

    Drug: Drug: ciprofol injection

Interventions

  • DrugDrug: ciprofol injection

    Patients in ciprofol group 0.3 mg/kg ciprofol for induction of anesthesia

06

What researchers measure

Primary outcomes

  1. Mean arterial pressure

    an average blood pressure in an individual during a single cardiac cycle

    Time frame: 1 second before induction of anesthesia (T1)

  2. Mean arterial pressure

    an average blood pressure in an individual during a single cardiac cycle

    Time frame: 1 second before tracheal intubation (T2)

  3. Mean arterial pressure

    an average blood pressure in an individual during a single cardiac cycle

    Time frame: 1 minute after tracheal intubation (T3)

  4. Mean arterial pressure

    an average blood pressure in an individual during a single cardiac cycle

    Time frame: 5 minutes after tracheal intubation (T4)

  5. Heart beats

    the number of times each minute that heart beats

    Time frame: 1 second before induction of anesthesia (T1)

  6. Heart beats

    the number of times each minute that heart beats

    Time frame: 1 second before tracheal intubation (T2)

  7. Heart beats

    the number of times each minute that heart beats

    Time frame: 1 minute after tracheal intubation (T3)

  8. Heart beats

    the number of times each minute that heart beats

    Time frame: 5 minutes after tracheal intubation (T4)

Secondary outcomes

  1. Oxygenation index

    a calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body.

    Time frame: 1 second before induction of anesthesia (T1)

  2. Oxygenation index

    a calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body.

    Time frame: 10 minutes after tracheal intubation (T5)

  3. Injection pain

    Pain at the injection site when injecting the drug(Evaluation with Visual Analogue Scale)

    Time frame: During procedure (When injecting the drug, ask the subject if the injection site is painful)

07

Study locations

1 of 1 sites recruiting
  • Shanghai East Hospital of Tongji University
    Shanghai, Shanghai 200120, China
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

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 Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06312345
Lead sponsor
Le Yu
Responsible party
Le Yu (Clinicians, Shanghai East Hospital of Tongji University) — Sponsor-investigator
First posted
Mar 15, 2024
Start date
Mar 11, 2024 (estimated)
Primary completion
May 1, 2024 (estimated)
Completion
May 10, 2024 (estimated)
Last update
Mar 15, 2024

Oversight

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

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