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seccsa: Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia

Sponsor
Le Yu (Other)
Overall Status
Recruiting
CT.gov ID
NCT05892471
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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. The investigators want to assesse the safety and effectiveness of ciprofol in cardiac surgery anesthesia

Condition or Disease Intervention/Treatment Phase
  • Drug: ciprofol injection
  • Drug: Propofol injection
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ciprofol

Drug: ciprofol injection
Patients in ciprofol group 0.3 mg/kg ciprofol for induction of anesthesia
Other Names:
  • Experimental

    		•
    Placebo Comparator: propofol

    Drug: Propofol injection
    Patients in propofol group received 1.5 mg/kg propofol for induction of anesthesia
    Other Names:
  • Placebo Comparator

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean arterial pressure [1 second before induction of anesthesia (T1)]

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

    2. Mean arterial pressure [1 second before tracheal intubation (T2)]

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

    3. Mean arterial pressure [1 minute after tracheal intubation (T3)]

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

    4. Mean arterial pressure [5 minutes after tracheal intubation (T4)]

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

    5. Heart beats [1 second before induction of anesthesia (T1)]

      the number of times each minute that heart beats

    6. Heart beats [1 second before tracheal intubation (T2)]

      the number of times each minute that heart beats

    7. Heart beats [1 minute after tracheal intubation (T3)]

      the number of times each minute that heart beats

    8. Heart beats [5 minutes after tracheal intubation (T4).]

      the number of times each minute that heart beats

    Secondary Outcome Measures

    1. Oxygenation index [1 second before induction of anesthesia (T1)]

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

    2. Oxygenation index [10 minutes after tracheal intubation (T5).]

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

    3. Injection pain [During procedure (When injecting the drug, ask the subject if the injection site is painful)]

      Pain at the injection site when injecting the drugļ¼ˆEvaluation with Visual Analogue Scaleļ¼‰

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 75 Years
    Sexes Eligible for Study:
    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:

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai East Hospital of Tongji University Shanghai Shanghai China 200120

    Sponsors and Collaborators

    • Le Yu

    Investigators

    • Study Director: Handong Sun, Shanghai East Hospital of Tongji University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Le Yu, Clinicians, Shanghai East Hospital of Tongji University
    ClinicalTrials.gov Identifier:
    NCT05892471
    Other Study ID Numbers:
    • 2022.8.1-2023.8.1
    First Posted:
    Jun 7, 2023
    Last Update Posted:
    Jun 7, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Propofol

    Study Results

    No Results Posted as of Jun 7, 2023