Clinical trial NCT05706337: Clinical Observation of Ciprofol for Anesthesia Induction
Official title: Clinical Observation of Ciprofol for Anesthesia Induction in the Elderly Undergoing Elective Non-cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Pain
Hemodynamic Instability
Keywords: Anesthesia induction
Ciprofol
propofol
Injection pain
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Hemodynamic changes：Systolic blood pressure (SBP)
timeFrame: From the beginning of drug administration to 30 minutes after intubation
measure: Hemodynamic changes: Diastolic blood pressure(DBP)
timeFrame: From the beginning of drug administration to 30 minutes after intubation
measure: Hemodynamic changes: Heart rate （HR ）
timeFrame: From the beginning of drug administration to 30 minutes after intubation
Secondary outcomes:
measure: adverse reactions: injection pain
timeFrame: anesthesia induction
measure: adverse reactions: muscle fasciculation
timeFrame: anesthesia induction
measure: adverse reactions：arrhythmia
timeFrame: anesthesia induction
measure: perioperative hepatic function: Aspartate Aminotransferase ( AST)
timeFrame: Before surgery , 1day after operation
measure: perioperative hepatic function: Alanine Aminotransferase ( ALT)
timeFrame: Before surgery , 1day after operation
measure: perioperative renal function: creatine
timeFrame: Before surgery , 1day after operation
measure: perioperative renal function:Blood Urea Nitrogen
timeFrame: Before surgery , 1day after operation
measure: Monitoring Depth of Anesthesia
timeFrame: anesthesia induction
Other outcomes:
Locations:
Study officials:
affiliation: Qian fo shan hospitial of shan dong province, China
name: Xiumei Song, Doctor
role: STUDY_CHAIR
References:
citation: Teng Y, Ou M, Wang X, Zhang W, Liu X, Liang Y, Li K, Wang Y, Ouyang W, Weng H, Li J, Yao S, Meng J, Shangguan W, Zuo Y, Zhu T, Liu B, Liu J. Efficacy and safety of ciprofol for the sedation/anesthesia in patients undergoing colonoscopy: Phase IIa and IIb multi-center clinical trials. Eur J Pharm Sci. 2021 Sep 1;164:105904. doi: 10.1016/j.ejps.2021.105904. Epub 2021 Jun 8.
citation: Wang X, Wang X, Liu J, Zuo YX, Zhu QM, Wei XC, Zou XH, Luo AL, Zhang FX, Li YL, Zheng H, Li H, Wang S, Wang DX, Guo QL, Liu CM, Wang YT, Zhu ZQ, Wang GY, Ai YQ, Xu MJ. Effects of ciprofol for the induction of general anesthesia in patients scheduled for elective surgery compared to propofol: a phase 3, multicenter, randomized, double-blind, comparative study. Eur Rev Med Pharmacol Sci. 2022 Mar;26(5):1607-1617. doi: 10.26355/eurrev_202203_28228.
citation: Qin K, Qin WY, Ming SP, Ma XF, Du XK. Effect of ciprofol on induction and maintenance of general anesthesia in patients undergoing kidney transplantation. Eur Rev Med Pharmacol Sci. 2022 Jul;26(14):5063-5071. doi: 10.26355/eurrev_202207_29292.