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

NCT05664386 | Unknown Phase 4

• 1 other identifier: 20221128C
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamics; Postoperative Recovery; Anesthesia

Keywords

Ciprofol; Hemodynamics; Postoperative Recovery; propofol

Outcome Measures

Primary Outcomes (4)

• 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: mean blood pressure (MAP)

  MAP 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

Secondary Outcomes (5)

• The time of lose consciousness（LOC） during the induction

  during anesthesia induction

• The incidence of adverse events during induction

  during induction

• quality of recovery

  pre-operation, postoperation of day 1 ,postoperation of day2

• postoperative recovery

  2 hours after surgery

• Incidence of intraoperative awareness

  2 hours after surgery

Study Arms (2)

propofol group

ACTIVE COMPARATOR

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

ciprofol group

EXPERIMENTAL

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

Interventions

propofol DRUG

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.

propofol group

ciprofol DRUG

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.

ciprofol group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology (ASA)Ⅰ～Ⅱ grade;
• years;
• Body mass index (BMI) 20-30kg/m2 ;
• Scheduled for thoracoscopic lobectomy under general anesthesia;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiumei Song: lead

Study Sites (1)

Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 34116176 BACKGROUND

• 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.

  PMID: 35302207 BACKGROUND

• 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.

  PMID: 35916802 BACKGROUND

• 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.

  PMID: 35922771 BACKGROUND

• 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.

  PMID: 36214498 BACKGROUND

• Guo N, Cao J, Duan M, Zhou F, Wang W, Xu L, Wei C, Song X. Effects of ciprofol infusion on hemodynamics during induction and maintenance of anesthesia and on postoperative recovery in patients undergoing thoracoscopic lobectomy: Study protocol for a randomized, controlled trial. PLoS One. 2024 Jul 10;19(7):e0305478. doi: 10.1371/journal.pone.0305478. eCollection 2024.

  PMID: 38985796 DERIVED

Related 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

MeSH Terms

Interventions

Propofol; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Xiumei Song, PH.D

  Qian fo shan hospitial of shan dong province, China

  STUDY CHAIR

Central Study Contacts

NA GUO, Doctor

CONTACT

18615605135; xinzangbianshu@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 23, 2022
• Study Start: April 10, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 1, 2024
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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
• Access Criteria: All registered researchers

Locations

CN (1)