Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery
1 other identifier
interventional
280
1 country
2
Brief Summary
Ciprofol is a novel 2,6-disubstituted phenol derivatives and is proved have much higher potency and tighter binding toward ɣ-aminobutyric acid type A (GABAA) receptor while maintaining a fast on-set and recovery time compared to propofol. Except lower incidence of hypotension and respiratory depression, it has no injection pain and infusion syndrome compared with propofol. There is no study to investigate overall postoperative functional recovery in patients receiving total intravenous anesthesia (TIVA) using ciprofol yet. However, according to study, early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery. Therefore, the purpose of this study is to determine whether there is any difference in the quality of postoperative recovery between ciprofol-based and propofol-based TIVA in elderly patients undergoing gastrointestinal surgery. The QoR-15 questionnaire score, pain, nausea/vomiting, and the frequency of complications are evaluated and compared between the two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
May 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedApril 9, 2024
May 1, 2023
1.5 years
April 3, 2023
April 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1
Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1(minimum value: 0, maximum value: 150, the higher the score, the better the result)
Postoperative day 1
Secondary Outcomes (12)
Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2
Postoperative day 2
Incidence of injection pain
during anesthesia induction
Hemodynamic change
During the operation
Vasoactive agents
from start of surgery to end of surgery
Tracheal extubation time
From stopping ciprofol or propofol infusion to awake and withdrawal of tracheal tube, approximately 30 minutes
- +7 more secondary outcomes
Study Arms (2)
Ciprofol group
EXPERIMENTALCiprofol-based total intravenous anesthesia is given for maintenance of general anesthesia
Propofol group
EXPERIMENTALPropofol-based total intravenous anesthesia is given for maintenance of general anesthesia
Interventions
Ciprofol group will be started and maintained total intravenous anesthesia with ciprofol and remifentanil
Propofol group will be started and maintained total intravenous anesthesia with propofol and remifentanil
Eligibility Criteria
You may qualify if:
- Patients undergoing elective laparoscopic surgery under endotracheal intubation and general anesthesia
- American Society of Anesthesiologists (ASA) classification: I to III;
- Age ≥ 60 years, BMI \< 30 kg/m2;
- Unconscious speech audiovisual impairment or unable to cooperate;
- Informed consent has been signed.
You may not qualify if:
- Taking any sedative, opioid, or sleep aid drugs;
- Psychiatric or neurological disorder;
- Allergic to ciprofol, propofol or soy, or a family history of malignant hyperthermia;
- Severe liver and kidney dysfunction;
- Operation duration \< 2 hours;
- Plan to the intensive care unit with tracheal catheter;
- Have participated in this study or other clinical studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (2)
Xijing Hospital
Xi'an, Shaanxi, 710032, China
Xijing Hospital
Xi'an, Shaanxi, China
Related Publications (6)
Qin L, Ren L, Wan S, Liu G, Luo X, Liu Z, Li F, Yu Y, Liu J, Wei Y. Design, Synthesis, and Evaluation of Novel 2,6-Disubstituted Phenol Derivatives as General Anesthetics. J Med Chem. 2017 May 11;60(9):3606-3617. doi: 10.1021/acs.jmedchem.7b00254. Epub 2017 Apr 28.
PMID: 28430430BACKGROUNDBian Y, Zhang H, Ma S, Jiao Y, Yan P, Liu X, Ma S, Xiong Y, Gu Z, Yu Z, Huang C, Miao L. Mass balance, pharmacokinetics and pharmacodynamics of intravenous HSK3486, a novel anaesthetic, administered to healthy subjects. Br J Clin Pharmacol. 2021 Jan;87(1):93-105. doi: 10.1111/bcp.14363. Epub 2020 Aug 3.
PMID: 32415708BACKGROUNDBakhtiari E, Mousavi SH, Gharavi Fard M. Pharmacological control of pain during propofol injection: a systematic review and meta-analysis. Expert Rev Clin Pharmacol. 2021 Jul;14(7):889-899. doi: 10.1080/17512433.2021.1919084. Epub 2021 Jun 1.
PMID: 33896305BACKGROUNDJalota L, Kalira V, George E, Shi YY, Hornuss C, Radke O, Pace NL, Apfel CC; Perioperative Clinical Research Core. Prevention of pain on injection of propofol: systematic review and meta-analysis. BMJ. 2011 Mar 15;342:d1110. doi: 10.1136/bmj.d1110.
PMID: 21406529BACKGROUNDLuo Z, Tu H, Zhang X, Wang X, Ouyang W, Wei X, Zou X, Zhu Z, Li Y, Shangguan W, Wu H, Wang Y, Guo Q. Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study. CNS Drugs. 2022 Mar;36(3):301-313. doi: 10.1007/s40263-021-00890-1. Epub 2022 Feb 14.
PMID: 35157236BACKGROUNDCampfort M, Cayla C, Lasocki S, Rineau E, Leger M. Early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery. J Clin Anesth. 2022 Jun;78:110638. doi: 10.1016/j.jclinane.2021.110638. Epub 2022 Jan 13.
PMID: 35033845BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Haopeng Zhang
Air Force Military Medical University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- participants were anesthetized and were unaware of the grouping. Care providers did not know the grouping. Specific investigators who did the intervention were aware of the grouping. The outcome assessors and the data analyzers did not know the grouping.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2023
First Posted
May 6, 2023
Study Start
May 16, 2023
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
April 9, 2024
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share