Clinical Observation of Ciprofol for Anesthesia Induction

Phase 4

Not yet recruiting

• Conditions: Pain; Anesthesia; Hemodynamic Instability
• Interventions: Drug: Ciprofol; Drug: Propofol

• Registration Number: NCT05706337
• Lead Sponsor: Xiumei Song

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-11-29
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-20
• Last Update Submitted: 2023-01-20
• Study First Posted: 2023-01-31
• Last Update Posted: 2023-01-31
• Study Start: 2023-02-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. ASA physical status Ⅰ-Ⅲ
2. Age over 65 years;
3. Body mass index (BMI) 20 ~ 30 kg/m2 ;
4. Elective noncardiac surgery;

Exclusion Criteria

1. The patient or his/her family refused to participate in the clinical trial;
2. Severe heart, lung, liver or kidney dysfunction;
3. Expected difficult airway, requiring awake tracheal intubation;
4. Those who are allergic to the drugs used in this study;
5. Unsuccessful tracheal intubation twice;
6. Patients with mental illness or impaired consciousness;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ciprofol group	Ciprofol	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.
propofol group	Propofol	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.

Primary Outcome Measures

Name	Time	Method
Hemodynamic changes: Diastolic blood pressure(DBP)	From the beginning of drug administration to 30 minutes after intubation	Diastolic blood pressure(DBP) during anesthesia induction
Hemodynamic changes: Heart rate （HR ）	From the beginning of drug administration to 30 minutes after intubation	Heart rate （HR ）during anesthesia induction
Hemodynamic changes：Systolic blood pressure (SBP)	From the beginning of drug administration to 30 minutes after intubation	Systolic blood pressure (SBP) during anesthesia induction

Secondary Outcome Measures

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