Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia (seccsa)

June 6, 2023 updated by: Le Yu
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Recruiting
        • Shanghai East Hospital of Tongji University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: propofol
Drug: Propofol injection
Patients in propofol group received 1.5 mg/kg propofol for induction of anesthesia
Other Names:
  • Placebo Comparator
Experimental: ciprofol
Drug: ciprofol injection
Patients in ciprofol group 0.3 mg/kg ciprofol for induction of anesthesia
Other Names:
  • Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial pressure
Time Frame: 1 second before induction of anesthesia (T1)
an average blood pressure in an individual during a single cardiac cycle
1 second before induction of anesthesia (T1)
Mean arterial pressure
Time Frame: 1 second before tracheal intubation (T2)
an average blood pressure in an individual during a single cardiac cycle
1 second before tracheal intubation (T2)
Mean arterial pressure
Time Frame: 1 minute after tracheal intubation (T3)
an average blood pressure in an individual during a single cardiac cycle
1 minute after tracheal intubation (T3)
Mean arterial pressure
Time Frame: 5 minutes after tracheal intubation (T4)
an average blood pressure in an individual during a single cardiac cycle
5 minutes after tracheal intubation (T4)
Heart beats
Time Frame: 1 second before induction of anesthesia (T1)
the number of times each minute that heart beats
1 second before induction of anesthesia (T1)
Heart beats
Time Frame: 1 second before tracheal intubation (T2)
the number of times each minute that heart beats
1 second before tracheal intubation (T2)
Heart beats
Time Frame: 1 minute after tracheal intubation (T3)
the number of times each minute that heart beats
1 minute after tracheal intubation (T3)
Heart beats
Time Frame: 5 minutes after tracheal intubation (T4).
the number of times each minute that heart beats
5 minutes after tracheal intubation (T4).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation index
Time Frame: 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.
1 second before induction of anesthesia (T1)
Oxygenation index
Time Frame: 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.
10 minutes after tracheal intubation (T5).
Injection pain
Time Frame: During procedure (When injecting the drug, ask the subject if the injection site is painful)
Pain at the injection site when injecting the drug（Evaluation with Visual Analogue Scale）
During procedure (When injecting the drug, ask the subject if the injection site is painful)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Le Yu

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

August 1, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022.8.1-2023.8.1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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