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Randomized Controlled Trial Comparative Study
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.
- Zenghui Liang, Jing Liu, Shuhan Chen, Xiaona Zhao, Gezi Chen, Yanle Xie, Dongmei Wang, Fei Xing, Yuanyuan Mao, Wei Zhang, Zhongyu Wang, and Jingjing Yuan.
- Department of Anesthesiology, Pain and Perioperative Medicine, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China; Henan Province International Joint Laboratory of Pain, Cognition and Emotion, Zhengzhou, Henan Province, China.
- J Clin Anesth. 2024 Dec 1; 99: 111660111660.
Study ObjectivesWe 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.DesignA prospective, double-blind, randomized non-inferiority trial was conducted in the theater, post-anesthesia care unit (PACU), and the ward.Participants144 elderly patients (age ≥ 65 years) were randomly assigned to either the ciprofol group or the propofol group.InterventionsThe ciprofol group received continuous infusion of ciprofol with remifentanil, and the propofol group received infusion of propofol with remifentanil.Outcome MeasuresThe 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 ResultsThe 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).ConclusionsCiprofol is not inferior to propofol in QoR. Ciprofol can be suitably administered to elderly patients undergoing elective laparoscopic major abdominal surgery.Copyright © 2024 Elsevier Inc. All rights reserved.
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