Clinical Observation of Ciprofol for Anesthesia Induction

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05706337
• Other study ID #: YXLL-KY-2022(060)
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Qianfoshan Hospital
• Contact: Xiumei Song, Doctor
• Phone: +8613969050425
• Email: ssm801117[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. ASA physical status ?-?

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;

Related Conditions & MeSH terms

• Anesthesia
• Hemodynamic Instability
• Pain

Intervention

Drug:
• Propofol
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.
• Ciprofol
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiumei Song

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic changes:Systolic blood pressure (SBP)	Systolic blood pressure (SBP) during anesthesia induction	From the beginning of drug administration to 30 minutes after intubation
Primary	Hemodynamic changes: Diastolic blood pressure(DBP)	Diastolic blood pressure(DBP) during anesthesia induction	From the beginning of drug administration to 30 minutes after intubation
Primary	Hemodynamic changes: Heart rate (HR )	Heart rate (HR )during anesthesia induction	From the beginning of drug administration to 30 minutes after intubation
Secondary	adverse reactions: injection pain	injection pain from propofol or ciprofol intravenous injection	anesthesia induction
Secondary	adverse reactions: muscle fasciculation	muscle fasciculation induced by propofol or ciprofol intravenous induction	anesthesia induction
Secondary	adverse reactions:arrhythmia	arrhythmia induced by propofol or ciprofol intravenous induction	anesthesia induction
Secondary	perioperative hepatic function: Aspartate Aminotransferase ( AST)	level of Aspartate Aminotransferase ( AST)	Before surgery , 1day after operation
Secondary	perioperative hepatic function: Alanine Aminotransferase ( ALT)	level of Alanine Aminotransferase ( ALT)	Before surgery , 1day after operation
Secondary	perioperative renal function: creatine	level of creatine	Before surgery , 1day after operation
Secondary	perioperative renal function:Blood Urea Nitrogen	level of Blood Urea Nitrogen(BUN)	Before surgery , 1day after operation
Secondary	Monitoring Depth of Anesthesia	BIS values	anesthesia induction

External Links

•   Liu J, Wang D , Zuo Y, MI W, Yao S, Yu W. Guidelines on clinical application of ciprofol. Chin J Anesthesiol, 2021,41 (2): 129-132