Quality of Postoperative Recovery in Older Patients Undergoing Day Surgery: A Randomized, Non-Inferiority Trial of Remimazolam versus Etomidate for Anesthesia Induction.

INTRODUCTION

This study compared the quality of postoperative recovery among older patients undergoing day surgery with induction using remimazolam or etomidate.

METHODS

This multicenter, randomized, parallel-group, double-blinded trial with a non-inferiority design was conducted in three tertiary university hospitals. Older patients undergoing day surgery were randomly assigned to receive either remimazolam or etomidate for pump-induced general anesthesia. The primary outcome was the 15-item Quality of Recovery (QoR-15) score on postoperative day 1 (POD1). The mean difference between the groups was compared against a non-inferiority margin of -8. Secondary outcomes included the QoR-15 score on POD2, scores for the five QoR-15 dimensions, and vital signs at predefined time points.

RESULTS

In total, 118 older patients were randomized to the two groups. In the per-protocol set, the QoR-15 score on POD1 was 133.7 ± 12.9 in the remimazolam group, versus 131.2 ± 17.3 in the etomidate group, with a mean difference of 2.5 [95% confidence interval [CI]: -3.2, 8.2). In the modified intention-to-treat set, the QoR-15 scores were 133.5 ± 12.9 and 131.2 ± 17.6 in the remimazolam and etomidate groups, respectively, with a mean difference of 2.3 (95% CI: -3.3, 7.8). The lower limit of the confidence interval exceeded the predefined non-inferiority cutoff of -8, confirming the non-inferiority of remimazolam (P < 0.001). We compared the QoR-15 dimension scores on POD1 with the baseline scores in both groups. In the remimazolam group, only the physical independence score on POD1 was higher than at baseline, whereas in the etomidate group, the total QoR-15, physical comfort, physical independence, and emotional state scores were all lower on POD1 than at baseline. During anesthesia maintenance, the remifentanil dosage was higher in the remimazolam group than in the etomidate group (890.1 ± 5.7 µg vs 745.1 ± 45.3 µg, P = 0.037).

CONCLUSION

In older patients undergoing day surgery, remimazolam exhibited non-inferiority to etomidate for anesthesia induction in terms of QoR-15 scores on POD1.