Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery

NCT ID: NCT05843383

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-16

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthetics, Intravenous Postoperative Complications Hypnotics and Sedatives Postoperative Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Ciprofol group

Ciprofol-based total intravenous anesthesia is given for maintenance of general anesthesia

Group Type EXPERIMENTAL

Ciprofol

Intervention Type DRUG

Ciprofol group will be started and maintained total intravenous anesthesia with ciprofol and remifentanil

Propofol group

Propofol-based total intravenous anesthesia is given for maintenance of general anesthesia

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Propofol group will be started and maintained total intravenous anesthesia with propofol and remifentanil

Interventions

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Ciprofol

Ciprofol group will be started and maintained total intravenous anesthesia with ciprofol and remifentanil

Intervention Type DRUG

Propofol

Propofol group will be started and maintained total intravenous anesthesia with propofol and remifentanil

Intervention Type DRUG

Other Intervention Names

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HSK3486 2,6-diisopropylphenol

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haopeng Zhang

Role: STUDY_CHAIR

Air Force Military Medical University, China

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status NOT_YET_RECRUITING

Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wanwan Yang

Role: CONTACT

029-84775343

Haopeng Zhang

Role: CONTACT

029-84775343

Facility Contacts

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Wanwan Yang

Role: primary

029-84775343

Wanwan Yang

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 28430430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32415708 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33896305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21406529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35157236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35033845 (View on PubMed)

Other Identifiers

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KY20222308-C-1

Identifier Type: -

Identifier Source: org_study_id

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