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
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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UNKNOWN
NA
280 participants
INTERVENTIONAL
2023-05-16
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ciprofol group
Ciprofol-based total intravenous anesthesia is given for maintenance of general anesthesia
Ciprofol
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
Propofol
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
Propofol
Propofol group will be started and maintained total intravenous anesthesia with propofol and remifentanil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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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
Xijing Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
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.
Other Identifiers
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KY20222308-C-1
Identifier Type: -
Identifier Source: org_study_id
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