Clinical trial NCT05843383: Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery
Official title: Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery in Elderly Patients Undergoing Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthetics, Intravenous
Postoperative Complications
Hypnotics and Sedatives
Postoperative Recovery
Keywords: Ciprofol
Propofol
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 280
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2
timeFrame: Postoperative day 2
measure: Incidence of injection pain
timeFrame: during anesthesia induction
measure: Hemodynamic change
timeFrame: During the operation
measure: Vasoactive agents
timeFrame: from start of surgery to end of surgery
measure: Tracheal extubation time
timeFrame: From stopping ciprofol or propofol infusion to awake and withdrawal of tracheal tube, approximately 30 minutes
measure: Postoperative sedation score
timeFrame: Immediately after awake，approximately 1 hour after surgery
measure: Postoperative pain score
timeFrame: Immediately after awake, approximately 1 hour after surgery
measure: Postoperative nausea and vomiting
timeFrame: Immediately after awake, approximately 1 hour after surgery
measure: First exhaust time
timeFrame: 24 hours after end of surgery, approximately 24 hours
measure: Hospital stay
timeFrame: From end of surgery to discharge from hospital, on an average of 7 days
measure: Postoperative complications
timeFrame: From end of surgery to discharge from hospital, on an average of 7 days
measure: Adverse event
timeFrame: From end of surgery to discharge from hospital, on an average of 7 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Haopeng Zhang
role: STUDY_CHAIR
References:
citation: 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.
citation: Bian 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.
citation: Bakhtiari 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.
citation: Jalota 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.
citation: Luo 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.
citation: Campfort 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.