Clinical trial NCT05664386: Effect of Ciprofol Infusion for Induction and Maintenance on Hemodynamics and Postoperative Recovery
Official title: Effect of Ciprofol Infusion for Induction and Maintenance on Hemodynamics and Postoperative Recovery in Patients Undergoing Thoracoscopic Lobectomy : a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hemodynamics
Postoperative Recovery
Anesthesia
Keywords: Ciprofol
Hemodynamics
Postoperative Recovery
propofol
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemodynamic fluctuations: Systolic blood pressure(SBP)
timeFrame: during anesthesia induction，perioperative
measure: Hemodynamic fluctuations: Diastolic blood pressure(DBP)
timeFrame: during anesthesia induction，perioperative
measure: Hemodynamic fluctuations: mean blood pressure (MAP)
timeFrame: during anesthesia induction，perioperative
measure: Hemodynamic fluctuations: Heart rate (HR)
timeFrame: during anesthesia induction，perioperative
Secondary outcomes:
measure: The time of lose consciousness（LOC） during the induction
timeFrame: during anesthesia induction
measure: The incidence of adverse events during induction
timeFrame: during induction
measure: quality of recovery
timeFrame: pre-operation, postoperation of day 1 ,postoperation of day2
measure: postoperative recovery
timeFrame: 2 hours after surgery
measure: Incidence of intraoperative awareness
timeFrame: 2 hours after surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Qian fo shan hospitial of shan dong province, China
name: Xiumei Song, PH.D
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.
citation: 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.
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.