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Clinical Trials/NCT06312345
NCT06312345
Recruiting
Not Applicable

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

Le Yu1 site in 1 country80 target enrollmentStarted: March 11, 2024Last updated:
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ConditionsAnesthesia
DrugsDrug: ciprofol injection

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Le Yu
Enrollment
80
Locations
1
Primary Endpoint
Heart beats
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
55 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •With a history of benzodiazepine allergy
  • •Significant liver or kidney insufficiency
  • •Coagulation dysfunction
  • •Neurological or psychiatric disorders
  • •Undergone major surgery within the past three months.

Outcomes

Primary Outcomes

Heart beats

Time Frame: 5 minutes after tracheal intubation (T4)

the number of times each minute that heart beats

Mean arterial pressure

Time Frame: 5 minutes after tracheal intubation (T4)

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

Secondary Outcomes

  • Injection pain(During procedure (When injecting the drug, ask the subject if the injection site is painful))
  • Oxygenation index(10 minutes after tracheal intubation (T5))

Investigators

Sponsor
Le Yu
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Le Yu

Clinicians

Shanghai East Hospital of Tongji University

Study Sites (1)

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