Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia

Study Overview
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Brief Summary
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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

Official Title
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Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: ciprofol injection
* Drug: Propofol injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ciprofol<br> | Drug: ciprofol injection<br>* Patients in ciprofol group 0.3 mg/kg ciprofol for induction of anesthesia<br>* Other names: Experimental;|
| Placebo Comparator: propofol<br> | Drug: Propofol injection<br>* Patients in propofol group received 1.5 mg/kg propofol for induction of anesthesia<br>* Other names: Placebo Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure | an average blood pressure in an individual during a single cardiac cycle | 1 second before induction of anesthesia (T1) | 
| Mean arterial pressure | an average blood pressure in an individual during a single cardiac cycle | 1 second before tracheal intubation (T2) | 
| Mean arterial pressure | an average blood pressure in an individual during a single cardiac cycle | 1 minute after tracheal intubation (T3) | 
| Mean arterial pressure | an average blood pressure in an individual during a single cardiac cycle | 5 minutes after tracheal intubation (T4) | 
| Heart beats | the number of times each minute that heart beats | 1 second before induction of anesthesia (T1) | 
| Heart beats | the number of times each minute that heart beats | 1 second before tracheal intubation (T2) | 
| Heart beats | the number of times each minute that heart beats | 1 minute after tracheal intubation (T3) | 
| Heart beats | the number of times each minute that heart beats | 5 minutes after tracheal intubation (T4). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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). | 
| 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) |