Minerva anestesiologica · 2026
Postoperative recovery with remimazolam versus propofol in elderly patients undergoing daytime ocular fundus surgery under general anesthesia: a multicenter randomized non-inferiority trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеСравнительное исследованиеEquivalence TrialПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Chen Hongya, Hu Sheng, Liu Fanfan, Gan Xiaoliang, He Honglian, Ye Weidi, Zhang Kehan, Liu Yunfei, Liu Yanyu, Wang Yue, Su Shaofei, Wang Guyan
Аннотация
BACKGROUND: Good quality of postoperative recovery is crucial for daytime surgery due to the short hospitalization and limited observation time. Remimazolam has unique advantages in hemodynamics for elders. This clinical trial compared remimazolam with propofol for the quality of postoperative recovery among elders who received ocular fundus daytime surgery.
METHODS: The current prospective, multicenter, randomized clinical trial recruited 291 elderly patients who underwent ocular fundus daytime surgery from five medical centers. All cases were classified into a remimazolam group (N.=145) given 0.3 mg/kg remimazolam to induce anesthesia and later1-2 mg/kg/h to maintain the anesthesia, or a propofol group (N.=146) given 1.5-3 mg/kg propofol to induce anesthesia and subsequently 4-10 mg/kg/h for the maintenance of anesthesia. The quality of recovery scale-15 (QoR-15) score 24 h postoperatively was the primary outcome.
RESULTS: The remimazolam group had comparable QoR-15 scores 24 h postoperatively compared to the propofol group (137.66 [8.53] vs. 138.24 [8.15]; mean difference [95% CI: -0.58 -2.50, 1.35]). The hemodynamics of the remimazolam group was more stable than in the propofol group. Relative to the propofol group, the time to consciousness loss during induction was prolonged, and the times for recovery after operation and laryngeal mask removal of the remimazolam group were shortened.
CONCLUSIONS: Remimazolam was non-inferior to propofol regarding postoperative recovery among elderly patients receiving ocular fundus daytime surgery. Compared to propofol, remimazolam facilitated more stable hemodynamics and shorter recovery times.
METHODS: The current prospective, multicenter, randomized clinical trial recruited 291 elderly patients who underwent ocular fundus daytime surgery from five medical centers. All cases were classified into a remimazolam group (N.=145) given 0.3 mg/kg remimazolam to induce anesthesia and later1-2 mg/kg/h to maintain the anesthesia, or a propofol group (N.=146) given 1.5-3 mg/kg propofol to induce anesthesia and subsequently 4-10 mg/kg/h for the maintenance of anesthesia. The quality of recovery scale-15 (QoR-15) score 24 h postoperatively was the primary outcome.
RESULTS: The remimazolam group had comparable QoR-15 scores 24 h postoperatively compared to the propofol group (137.66 [8.53] vs. 138.24 [8.15]; mean difference [95% CI: -0.58 -2.50, 1.35]). The hemodynamics of the remimazolam group was more stable than in the propofol group. Relative to the propofol group, the time to consciousness loss during induction was prolonged, and the times for recovery after operation and laryngeal mask removal of the remimazolam group were shortened.
CONCLUSIONS: Remimazolam was non-inferior to propofol regarding postoperative recovery among elderly patients receiving ocular fundus daytime surgery. Compared to propofol, remimazolam facilitated more stable hemodynamics and shorter recovery times.