对接受腹腔镜大腹部手术的老年患者进行全静脉麻醉时，比较异丙酚和丙泊酚的术后恢复质量：随机、对照、双盲、非劣效试验。

IF 5 2区医学 Q1 ANESTHESIOLOGY

Journal of Clinical Anesthesia Pub Date : 2024-10-18 DOI:10.1016/j.jclinane.2024.111660

Zenghui Liang MMed , Jing Liu MMed , Shuhan Chen MMed , Xiaona Zhao MMed , Gezi Chen MMed , Yanle Xie MMed , Dongmei Wang MMed , Fei Xing MMed , Yuanyuan Mao MMed , Wei Zhang MD , Zhongyu Wang MD , Jingjing Yuan MD

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引用次数: 0

摘要

研究目的我们开展了一项非劣效性研究，以QoR-15评分为主要测量指标，评估择期腹腔镜大腹部手术后接受异丙酚或丙泊酚全静脉麻醉（TIVA）的老年患者的术后恢复质量（QoR）：设计：在手术室、麻醉后护理病房（PACU）和病房进行前瞻性、双盲、随机非劣效性试验：144名老年患者（年龄≥65岁）被随机分配到异丙酚组或丙泊酚组：干预措施：环丙酚组持续输注环丙酚和瑞芬太尼，丙泊酚组输注丙泊酚和瑞芬太尼：主要结果是术后第一天（POD1）的QoR-15，在意向治疗组和按方案治疗组中进行评估，组间平均差异与非劣效阈值-8进行比较。在意向治疗分析中，其他评估的围手术期价值因素包括血液动力学参数和注射不适感。利用线性混合模型研究了组间时间交互作用对血液动力学数据和 QoR-15 的影响：主要结果：在意向治疗组中，环丙酚组 POD1 的 QoR-15 评分均不劣于异丙酚组（平均值[95 %CI]，95.9[93.7-98.2] vs. 95.6 [93.3-97.8]；平均差[95 %CI]，0.4 [-2.8-3.5] ；PC 结论：环丙酚不劣于异丙酚：在QoR方面，异丙酚并不逊色于丙泊酚。接受择期腹腔镜大腹部手术的老年患者可以适当使用异丙酚。

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Postoperative quality of recovery comparison between ciprofol and propofol in total intravenous anesthesia for elderly patients undergoing laparoscopic major abdominal surgery: A randomized, controlled, double-blind, non-inferiority trial

Study objectives

We conducted a non-inferiority study to assess the postoperative quality of recovery (QoR) in elderly patients receiving ciprofol or propofol total intravenous anesthersia(TIVA)after elective laparoscopic major abdominal surgery, with QoR-15 scores as the main measure.

Design

A prospective, double-blind, randomized non-inferiority trial was conducted in the theater, post-anesthesia care unit (PACU), and the ward.

Participants

144 elderly patients (age ≥ 65 years) were randomly assigned to either the ciprofol group or the propofol group.

Interventions

The ciprofol group received continuous infusion of ciprofol with remifentanil, and the propofol group received infusion of propofol with remifentanil.

Outcome measures

The primary outcome was the QoR-15 on the first postoperative day (POD1), assessed in both intention-to-treat and per-protocol populations, with the mean difference between groups compared to a non-inferiority threshold of −8. Additional assessments included QoR-15 scores on POD2, 3, and 5 for both analysis sets. Other evaluated perioperative value factors included hemodynamic parameters and injection discomfort in the intention-to-treat analysis. A linear mixed model was utilized to examine the impact of group-time interactions on hemodynamic data and QoR-15.

Main results

The QoR-15 scores on POD1 in the ciprofol group were non-inferior to those in the propofol group both in intention-to-treat set (mean [95 %CI], 95.9[93.7–98.2] vs. 95.6 [93.3–97.8]; mean difference [95 % CI], 0.4 [−2.8–3.5]; P<0.001 for noninferiority) and per-protocol set (mean [95 %CI], 96.7 [94.4–99.0] vs. 95.7 [93.4–98.0]; mean difference [95 % CI], 1.0 [−2.2–4.3]; P<0.001 for noninferiority). Comparable outcomes were noted on postoperative days 2, 3, and 5 following the procedure in both analysis sets. Additionally: compared with propofol group, the occurrence of injection pain was lower (2.8 % vs. 27.8 %, P < 0.001); the hypotension was less frequent (33.3 % vs. 54.2 %, P = 0.012); the bradycardia was more common (38.9 % vs. 23.6 %, P = 0.048).

Conclusions

Ciprofol is not inferior to propofol in QoR. Ciprofol can be suitably administered to elderly patients undergoing elective laparoscopic major abdominal surgery.

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来源期刊

Journal of Clinical Anesthesia 医学-麻醉学

CiteScore

7.40

自引率

4.50%

发文量

346

审稿时长

23 days

期刊介绍： The Journal of Clinical Anesthesia (JCA) addresses all aspects of anesthesia practice, including anesthetic administration, pharmacokinetics, preoperative and postoperative considerations, coexisting disease and other complicating factors, cost issues, and similar concerns anesthesiologists contend with daily. Exceptionally high standards of presentation and accuracy are maintained. The core of the journal is original contributions on subjects relevant to clinical practice, and rigorously peer-reviewed. Highly respected international experts have joined together to form the Editorial Board, sharing their years of experience and clinical expertise. Specialized section editors cover the various subspecialties within the field. To keep your practical clinical skills current, the journal bridges the gap between the laboratory and the clinical practice of anesthesiology and critical care to clarify how new insights can improve daily practice.