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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofol group | Experimental | Ciprofol-based total intravenous anesthesia is given for maintenance of general anesthesia |
|
| Propofol group | Experimental | Propofol-based total intravenous anesthesia is given for maintenance of general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofol | Drug | Ciprofol group will be started and maintained total intravenous anesthesia with ciprofol and remifentanil |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2 | Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2 (minimum value: 0, maximum value: 150, the higher the score, the better the result) | Postoperative day 2 |
| Incidence of injection pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wanwan Yang | Contact | 029-84775343 | yangwanwan2017@163.com | |
| Haopeng Zhang | Contact | 029-84775343 | haopeng.zhang@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Haopeng Zhang | Air Force Military Medical University, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Not yet recruiting | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28430430 | Background | 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. | |
| 32415708 | Background | 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. |
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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.
| Propofol | Drug | Propofol group will be started and maintained total intravenous anesthesia with propofol and remifentanil |
|
|
Record the incidence of injection pain ( yes or no) |
| during anesthesia induction |
| Hemodynamic change | Record the mean arterial pressure (MAP) at different points, including before induction, after induction, immediately after intubation, at the beginning of surgery, at the end of anesthesia, immediately after extubation, and before leaving the room | During the operation |
| Vasoactive agents | Percentage of patients needed vasoactive agents during anesthesia | from start of surgery to end of surgery |
| Tracheal extubation time | Time from cessation of main anaesthetics to tracheal extubation | From stopping ciprofol or propofol infusion to awake and withdrawal of tracheal tube, approximately 30 minutes |
| Postoperative sedation score | Monitored by the sedation scale called Sedation-Agitation Scale (SAS). SAS is a medical scale used to measure the agitation or sedation level of a person.The score ranges from 1 to 7 | Immediately after awake，approximately 1 hour after surgery |
| Postoperative pain score | postoperative pain score measured by 11-point VAS (Visual Analogue Scale) score (minimum : 0, maximum : 10, the lower the score, the lesser pain) | Immediately after awake, approximately 1 hour after surgery |
| Postoperative nausea and vomiting | Postoperative nausea and vomiting will be evaluated by PONV (Post Operative Nausea And Vomiting) score (no : 0, vomit: 4) | Immediately after awake, approximately 1 hour after surgery |
| First exhaust time | Record the first exhaust time After the operation | 24 hours after end of surgery, approximately 24 hours |
| Hospital stay | days of hospital stay | From end of surgery to discharge from hospital, on an average of 7 days |
| Postoperative complications | Various complications occurred during hospitalization | From end of surgery to discharge from hospital, on an average of 7 days |
| Adverse event | Percentage of adverse events occurred during hospitalization | From end of surgery to discharge from hospital, on an average of 7 days |
| Xijing Hospital | Recruiting | Xi'an | Shaanxi | China |
|
| 33896305 | Background | 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. |
| 21406529 | Background | 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. |
| 35157236 | Background | 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. |
| 35033845 | Background | 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. |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| C000730813 | HSK3486 |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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