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

Study Overview
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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.

Official Title
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Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery in Elderly Patients Undergoing Gastrointestinal Surgery

Conditions
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Anesthetics, Intravenous, Postoperative Complications, Hypnotics and Sedatives, Postoperative Recovery

Intervention / Treatment
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* Drug: Ciprofol
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective gastrointestinal 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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ciprofol group<br>Ciprofol-based total intravenous anesthesia is given for maintenance of general anesthesia | Drug: Ciprofol<br>* Ciprofol group will be started and maintained total intravenous anesthesia with ciprofol and remifentanil<br>* Other names: HSK3486;|
| Experimental: Propofol group<br>Propofol-based total intravenous anesthesia is given for maintenance of general anesthesia | Drug: Propofol<br>* Propofol group will be started and maintained total intravenous anesthesia with propofol and remifentanil<br>* Other names: 2,6-diisopropylphenol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ciprofol, Propofol