Clinical Observation of Ciprofol for Anesthesia Induction

Study Overview
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Brief Summary
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To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial.

Detailed Description
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90 elderly patients undergoing noncardiac surgery were randomly divided into propofol group and ciprofol group, who were given propofol 1   2mg/kg or ciprofol 0.2-0.5mg/kg during anesthesia induction respectively. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and BIS values at various time points during anesthesia induction were collected. At the same time, rates of injection pain, muscle fasciculation, arrhythmia, cough and perioperative hepatic and renal functions were compared between the two groups. The primary outcomes were the fluctuations in hemodynamic parameters during induction. The secondary outcome were adverse reactions, BIS values and changes of hepatic and renal functions during induction.

Official Title
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Clinical Observation of Ciprofol for Anesthesia Induction in the Elderly Undergoing Elective Non-cardiac Surgery

Conditions
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Pain, Anesthesia, Hemodynamic Instability

Intervention / Treatment
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* Drug: Propofol
* Drug: Ciprofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status Ⅰ-Ⅲ Age over 65 years; Body mass index (BMI) 20   30 kg/m2 ; Elective noncardiac surgery; Exclusion Criteria: The patient or his/her family refused to participate in the clinical trial; Severe heart, lung, liver or kidney dysfunction; Expected difficult airway, requiring awake tracheal intubation; Those who are allergic to the drugs used in this study; Unsuccessful tracheal intubation twice; Patients with mental illness or impaired consciousness;

Ages Eligible for Study
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Minimum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol group<br>According to grouping，patients were premeditated with injection of Propofol 1-2mg / kg IV . If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, propofol 0.5mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil. | Drug: Propofol<br>* Propofol 1-2mg / kg was for anesthesia induction. Propofol is a hypnotic agent that is used as an induction agent and as a maintenance anaesthetic delivered by continuous i.v. infusion or intermittent i.v. bolus.<br>|
| Experimental: ciprofol group<br>According to grouping，patients were premeditated with injection of ciprofol 0.2-0.5mg/kg IV. If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, ciprofol 0.1mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil in both groups. | Drug: Ciprofol<br>* Ciprofol 0.2～0.5mg/kg was for anesthesia induction. Ciprofol is an intravenous sedative-hypnotic and a short-acting GABAA receptor agonist. It activates GABAergic neurons by enhancing chloride ion influx. It is used for anesthetic induction and maintenance agents include rapid induction of general anesthesia, rapid return of consciousness, minimal residual effects on the central nervous system and less injection pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic changes：Systolic blood pressure (SBP) | Systolic blood pressure (SBP) during anesthesia induction | From the beginning of drug administration to 30 minutes after intubation | 
| Hemodynamic changes: Diastolic blood pressure(DBP) | Diastolic blood pressure(DBP) during anesthesia induction | From the beginning of drug administration to 30 minutes after intubation | 
| Hemodynamic changes: Heart rate （HR ） | Heart rate （HR ）during anesthesia induction | From the beginning of drug administration to 30 minutes after intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse reactions: injection pain | injection pain from propofol or ciprofol intravenous injection | anesthesia induction | 
| adverse reactions: muscle fasciculation | muscle fasciculation induced by propofol or ciprofol intravenous induction | anesthesia induction | 
| adverse reactions：arrhythmia | arrhythmia induced by propofol or ciprofol intravenous induction | anesthesia induction | 
| perioperative hepatic function: Aspartate Aminotransferase ( AST) | level of Aspartate Aminotransferase ( AST) | Before surgery , 1day after operation | 
| perioperative hepatic function: Alanine Aminotransferase ( ALT) | level of Alanine Aminotransferase ( ALT) | Before surgery , 1day after operation | 
| perioperative renal function: creatine | level of creatine | Before surgery , 1day after operation | 
| perioperative renal function:Blood Urea Nitrogen | level of Blood Urea Nitrogen（BUN) | Before surgery , 1day after operation | 
| Monitoring Depth of Anesthesia | BIS values | anesthesia induction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia induction, Ciprofol, propofol, Injection pain