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

Le Yu

Status: Enrolling

Conditions: Anesthesia

Treatments: Drug: Propofol injection; Drug: ciprofol injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05892471

2022.8.1-2023.8.1

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 2 patient groups, including a placebo group

ciprofol

Experimental group

Treatment:

Drug: ciprofol injection

propofol

Placebo Comparator group

Treatment:

Drug: Propofol injection