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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312345
• Other study ID #: 2024.3.10-2024.5.1
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: May 10, 2024

Study information

• Verified date: March 2024
• Source: Shanghai East Hospital of Tongji University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 10, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
China	Shanghai East Hospital of Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Le Yu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial pressure	an average blood pressure in an individual during a single cardiac cycle	1 second before induction of anesthesia (T1)
Primary	Mean arterial pressure	an average blood pressure in an individual during a single cardiac cycle	1 second before tracheal intubation (T2)
Primary	Mean arterial pressure	an average blood pressure in an individual during a single cardiac cycle	1 minute after tracheal intubation (T3)
Primary	Mean arterial pressure	an average blood pressure in an individual during a single cardiac cycle	5 minutes after tracheal intubation (T4)
Primary	Heart beats	the number of times each minute that heart beats	1 second before induction of anesthesia (T1)
Primary	Heart beats	the number of times each minute that heart beats	1 second before tracheal intubation (T2)
Primary	Heart beats	the number of times each minute that heart beats	1 minute after tracheal intubation (T3)
Primary	Heart beats	the number of times each minute that heart beats	5 minutes after tracheal intubation (T4)
Secondary	Oxygenation index	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)
Secondary	Oxygenation index	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)
Secondary	Injection pain	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)