Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia

Not Applicable

Recruiting

• Conditions: Anesthesia
• Interventions: Drug: ciprofol injection; Drug: Propofol injection

• Registration Number: NCT05892471
• 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. The investigators want to assesse the safety and effectiveness of ciprofol in cardiac surgery anesthesia

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2023-05-17
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-06
• Last Update Submitted: 2023-06-06
• Study First Posted: 2023-06-07
• Last Update Posted: 2023-06-07
• Primary Completion: 2023-08-01
• Study Completion: 2023-09-01

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

Arm && Interventions

Group	Intervention	Description
ciprofol	ciprofol injection	-
propofol	Propofol injection	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
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）

Trial Locations

Locations (1)

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