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

Not Applicable

Recruiting

• Conditions: Hypnotics and Sedatives; Postoperative Recovery; Postoperative Complications; Anesthetics, Intravenous
• Interventions: Drug: Ciprofol; Drug: Propofol

• Registration Number: NCT05843383
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-24
• Status Verified: 2023-05
• Study First Posted: 2023-05-06
• Study Start: 2023-05-16
• Last Update Submitted: 2024-04-06
• Last Update Posted: 2024-04-09
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciprofol group	Ciprofol	Ciprofol-based total intravenous anesthesia is given for maintenance of general anesthesia
Propofol group	Propofol	Propofol-based total intravenous anesthesia is given for maintenance of general anesthesia

Primary Outcome Measures

Name	Time	Method
Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1	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)

Secondary Outcome Measures

Name	Time	Method
Incidence of injection pain	during anesthesia induction	Record the incidence of injection pain ( yes or no)
First exhaust time	24 hours after end of surgery, approximately 24 hours	Record the first exhaust time After the operation
Adverse event	From end of surgery to discharge from hospital, on an average of 7 days	Percentage of adverse events occurred during hospitalization
Tracheal extubation time	From stopping ciprofol or propofol infusion to awake and withdrawal of tracheal tube, approximately 30 minutes	Time from cessation of main anaesthetics to tracheal extubation
Hemodynamic change	During the operation	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
Postoperative pain score	Immediately after awake, approximately 1 hour after surgery	postoperative pain score measured by 11-point VAS (Visual Analogue Scale) score (minimum : 0, maximum : 10, the lower the score, the lesser pain)
Postoperative nausea and vomiting	Immediately after awake, approximately 1 hour after surgery	Postoperative nausea and vomiting will be evaluated by PONV (Post Operative Nausea And Vomiting) score (no : 0, vomit: 4)
Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2	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)
Vasoactive agents	from start of surgery to end of surgery	Percentage of patients needed vasoactive agents during anesthesia
Postoperative complications	From end of surgery to discharge from hospital, on an average of 7 days	Various complications occurred during hospitalization
Postoperative sedation score	Immediately after awake，approximately 1 hour after surgery	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
Hospital stay	From end of surgery to discharge from hospital, on an average of 7 days	days of hospital stay

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China