Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery in Elderly Patients Undergoing Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ciprofol group
Ciprofol-based total intravenous anesthesia is given for maintenance of general anesthesia
干预措施: Ciprofol (Drug)
Propofol group
Propofol-based total intravenous anesthesia is given for maintenance of general anesthesia
干预措施: Propofol (Drug)
结局指标
主要结局
Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1
时间窗: 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)
次要结局
- Incidence of injection pain(during anesthesia induction)
- First exhaust time(24 hours after end of surgery, approximately 24 hours)
- Adverse event(From end of surgery to discharge from hospital, on an average of 7 days)
- Tracheal extubation time(From stopping ciprofol or propofol infusion to awake and withdrawal of tracheal tube, approximately 30 minutes)
- Hemodynamic change(During the operation)
- Postoperative pain score(Immediately after awake, approximately 1 hour after surgery)
- Postoperative nausea and vomiting(Immediately after awake, approximately 1 hour after surgery)
- Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2(Postoperative day 2)
- Vasoactive agents(from start of surgery to end of surgery)
- Postoperative complications(From end of surgery to discharge from hospital, on an average of 7 days)
- Postoperative sedation score(Immediately after awake，approximately 1 hour after surgery)
- Hospital stay(From end of surgery to discharge from hospital, on an average of 7 days)