Journal Article

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

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

2024

Overview

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<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). Ciprofol is not inferior to propofol in QoR. Ciprofol can be suitably administered to elderly patients undergoing elective laparoscopic major abdominal surgery. •Ciprofol is a novel intravenous anesthetic agent.•Ciprofol offers a comparable quality of recovery to propofol, with reduced injection pain, more stable intraoperative hemodynamics.•For elderly patients with cardiovascular diseases undergoing major laparoscopic surgery, ciprofol may be preferable to propofol.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: 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 / Pain Medicine / Patients / Perioperative care / Propofol - administration & dosage / Propofol - adverse effects / Prospective Studies / QoR-15 / Recovery (Medical) / Remifentanil - administration & dosage / Remifentanil - adverse effects / Side effects / TIVA