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.