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

Not Applicable

Recruiting

• Conditions: Anesthesia

• Registration Number: NCT06312345
• Lead Sponsor: Le Yu

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-10
• Last Update Submitted: 2024-03-10
• Study Start: 2024-03-11
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heart beats	5 minutes after tracheal intubation (T4)	the number of times each minute that heart beats
Mean arterial pressure	5 minutes after tracheal intubation (T4)	an average blood pressure in an individual during a single cardiac cycle

Secondary Outcome Measures

Name	Time	Method
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 drug（Evaluation with Visual Analogue Scale）
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.

Trial Locations

Locations (1)

Shanghai East Hospital of Tongji University; 🇨🇳 Shanghai, Shanghai, China