Effect of Ciprofol Infusion for Induction and Maintenance on Hemodynamics and Postoperative Recovery

Anesthesia Clinical Trial

Official title:

Effect of Ciprofol Infusion for Induction and Maintenance on Hemodynamics and Postoperative Recovery in Patients Undergoing Thoracoscopic Lobectomy : a Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664386
• Other study ID #: 20221128C
• Status: Recruiting
• Phase: Phase 4
• Start date: April 10, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Qianfoshan Hospital
• Contact: NA GUO, Doctor
• Phone: 18615605135
• Email: xinzangbianshu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the Effect of Ciprofol Infusion for Induction and Maintenance of anesthesia on Hemodynamics and Postoperative Recovery in Patients Undergoing Thoracoscopic Lobectomy:a randomized, controlled trial.

Description:

Patients undergoing Thoracoscopic Lobectomy aged 18~65 years old were randomly assigned to Group P and Group C . Group P was given propofol 2 ~ 2.5mg/kg, group C was given ciprofol 0.4 ~ 0.5mg/kg, if bispectral index(BIS) value ≤60 during anesthesia induction, cisatracurium 0.2mg/kg and sufentanil 0.5μg/kg were injected intravenously, endotracheal intubation was performed after the improvement of muscle relaxation. If the BIS value was greater than 60, propofol was added intravenously 1mg/kg each time or ciprofol 0.2mg/kg each time, and the interval of administration was greater than 1min, until BIS≤60. Cisatracurium and sufentanil were injected intravenously, followed by endotracheal intubation.Then propofol was maintained in group P at 4-12 mg/kg/h and remifentanil was maintained at 0.1-0.3 ug/kg/min .Ciprofol was maintained in Group C at 0.8-2.5 mg/kg/h and remifentanil was maintained at 0.1-0.3 ug/kg/min . Intermittent addition of cisatracurium. Sufentanil was added as required, and total dosage of Sufentanil was 0.7ug ~ 1ug/kg. BIS was kept at 40 ~ 60 during the surgery, and infusion drugs were stopped at the end of the operation. The patients were Transfer to Postanesthesia care unit(PACU) after the operation.

The primary outcomes were the fluctuations in hemodynamic parameters during induction and the surgery. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP),heart rate (HR) and BIS values at various time points were collected.

The secondary outcome were as follows:

1. The time of lose consciousness（LOC） during the induction, The Time and dosage of additional drug, and the BIS value during the induction process.

2. The incidence of adverse events such as injection pain, body movement, muscle twitching, hypotension, hypertension, bradycardia or tachycardia, cough and bronchospasm during induction.

3. quality of recovery 15（QOR15） score at pre-operation（Preop） 、on the first day of postoperation （POD1）and on the second day of postoperation （POD2） .

4. the recovery time of consciousness (ROC）, extubation time, PACU stay time, postoperative hospital stay time.

5. Incidence of postoperative nausea and vomiting, incidence of postoperative agitation and delayed recovery, and intraoperative awareness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiology (ASA)?~? grade;

• 18-65 years;

• Body mass index (BMI) 20-30kg/m2 ;

• Scheduled for thoracoscopic lobectomy under general anesthesia;

Exclusion Criteria:

• Refused to participate in the clinical study;

• Predictable airway difficulties requiring awake intubation;

• Allergy to the drugs which were used in this study;

• Tracheal intubation failed for twice;

• Patients with mental diseases or consciousness disorder;

• long-term use of sedatives or Antidepressants;

• Patients who are participating in other clinical studies.

Related Conditions & MeSH terms

• Anesthesia
• Hemodynamics
• Postoperative Recovery

Intervention

Drug:
• propofol
propofol 2~2.5mg/kg was used for anesthesia induction. propofol 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 anesthesia of induction and maintenance.
• ciprofol
Ciprofol 0.4~0.5mg/kg was used 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 recovery of consciousness, minimal residual effects on the central nervous system and less injection pain.

Locations

Country	Name	City	State
China	Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Xiumei Song

Country where clinical trial is conducted

China, 

References & Publications (5)

Chen BZ, Yin XY, Jiang LH, Liu JH, Shi YY, Yuan BY. The efficacy and safety of ciprofol use for the induction of general anesthesia in patients undergoing gynecological surgery: a prospective randomized controlled study. BMC Anesthesiol. 2022 Aug 3;22(1):245. doi: 10.1186/s12871-022-01782-7. — View Citation

Ding YY, Long YQ, Yang HT, Zhuang K, Ji FH, Peng K. Efficacy and safety of ciprofol for general anaesthesia induction in elderly patients undergoing major noncardiac surgery: A randomised controlled pilot trial. Eur J Anaesthesiol. 2022 Dec 1;39(12):960-963. doi: 10.1097/EJA.0000000000001759. No abstract available. — View 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. — 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 fluctuations: Systolic blood pressure(SBP)	Systolic blood pressure(SBP) during anesthesia induction and surgery.	during anesthesia induction,perioperative
Primary	Hemodynamic fluctuations: Diastolic blood pressure(DBP)	Diastolic blood pressure(DBP) during anesthesia induction and surgery.	during anesthesia induction,perioperative
Primary	Hemodynamic fluctuations: mean blood pressure (MAP)	MAP during anesthesia induction and surgery.	during anesthesia induction,perioperative
Primary	Hemodynamic fluctuations: Heart rate (HR)	Heart rate (HR) during anesthesia induction and surgery.	during anesthesia induction,perioperative
Secondary	The time of lose consciousness(LOC) during the induction	The time of lose consciousness(LOC) during the induction was defined as from the drug was administered until the patients loss of consciousness(when the BIS=60)	during anesthesia induction
Secondary	The incidence of adverse events during induction	The incidence of adverse events such as injection pain, body movement, muscle twitching, hypotension, hypertension, bradycardia or tachycardia, cough and bronchospasm during induction.	during induction
Secondary	quality of recovery	quality of recovery 15(QOR15) score at pre-operation(Preop) ? postoperation day 1 ,postoperation of day2	pre-operation, postoperation of day 1 ,postoperation of day2
Secondary	postoperative recovery	Incidence of postoperative nausea and vomiting was record use Classification of nausea and vomiting	2 hours after surgery
Secondary	Incidence of intraoperative awareness	Brice Questionnaire was used to assess the occurrence of intraoperative awareness.	2 hours after surgery

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