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

• Published in: Journal of clinical anesthesia 2024-12, Vol.99, p.111660, Article 111660
• Main Authors: Liang, Zenghui, Liu, Jing, Chen, Shuhan, Zhao, Xiaona, Chen, Gezi, Xie, Yanle, Wang, Dongmei, Xing, Fei, Mao, Yuanyuan, Zhang, Wei, Wang, Zhongyu, Yuan, Jingjing
• Format: Article
• Language: English
• Subjects: Abdomen - surgery; Abdominal surgery; Aged; Aged, 80 and over; Anesthesia; Anesthesia Recovery Period; Anesthesia, Intravenous - methods; Anesthetics, Intravenous - administration & dosage; Anesthetics, Intravenous - adverse effects; Blood pressure; Cardiac arrhythmia; Ciprofol; Clinical trials; Cyclopropanes; Data collection; Double-Blind Method; Drug dosages; Elderly patients; Extubation; Female; Hemodynamics; Humans; Laparoscopy; Laparoscopy - adverse effects; Laparoscopy - methods; Male; Non-inferiority; Pain; Patients; Perioperative care; Propofol - administration & dosage; Propofol - adverse effects; Prospective Studies; QoR-15; Recovery (Medical); Remifentanil - administration & dosage; Remifentanil - adverse effects; Side effects; TIVA
• ISSN: 0952-8180; 1873-4529; 1873-4529
• DOI: 10.1016/j.jclinane.2024.111660

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. A prospective, double-blind, randomized non-inferiority trial was conducted in the theater, post-anesthesia care unit (PACU), and the ward. 144 elderly patients (age ≥ 65 years) were randomly assigned to either the ciprofol group or the propofol group. The ciprofol group received continuous infusion of ciprofol with remifentanil, and the propofol group received infusion of propofol with remifentanil. 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. 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