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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Hemodynamics; Postoperative Recovery
• Intervention / Treatment: Drug: propofol; Drug: ciprofol

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: NA GUO, Doctor; Phone Number: 18615605135; Email: xinzangbianshu@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
      • Contact: NA GUO, master; Phone Number: 18615605135; Email: xinzangbianshu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• American Society of Anesthesiology (ASA)Ⅰ～Ⅱ 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: propofol group; According to grouping，patients were premeditated with injection of Propofol 2-2.5mg / 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, propofol 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.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 .BIS was kept at 40 ~ 60 during the surgery, and infusion drugs were stopped at the end of the operation. The patients were Transfered to Postanesthesia care unit(PACU) after the operation.	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.
Experimental: ciprofol group; 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, 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 endotrachealintubation.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 Transfered to Postanesthesia care unit(PACU) after the operation.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic fluctuations: Systolic blood pressure(SBP)	Systolic blood pressure(SBP) during anesthesia induction and surgery.	during anesthesia induction，perioperative
Hemodynamic fluctuations: Diastolic blood pressure(DBP)	Diastolic blood pressure(DBP) during anesthesia induction and surgery.	during anesthesia induction，perioperative
Hemodynamic fluctuations: Heart rate (HR)	Heart rate (HR) during anesthesia induction and surgery.	during anesthesia induction，perioperative
Hemodynamic fluctuations: mean blood pressure (MAP)	MAP during anesthesia induction and surgery.	during anesthesia induction，perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
postoperative recovery	Incidence of postoperative nausea and vomiting was record use Classification of nausea and vomiting	2 hours after surgery
Incidence of intraoperative awareness	Brice Questionnaire was used to assess the occurrence of intraoperative awareness.	2 hours after surgery

Collaborators and Investigators

• Sponsor: Xiumei Song
• Investigators: Study Chair: Xiumei Song, PH.D, Qian fo shan hospitial of shan dong province, China

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: December 17, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: propofol; Hemodynamics; Ciprofol; Postoperative Recovery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 20221128C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to upload and share data with other researchers. Protecting patient privacy when sharing patient-level data from clinical trial
• IPD Sharing Time Frame: study protocol and Informed Consent Form will available before 2024/1/1 Statistical Analysis Plan and Clinical Study Report will available before 2024/6/1
• IPD Sharing Access Criteria: All registered researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No