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Randomized Controlled Trial
. 2024 Oct 18:18:4615-4627.
doi: 10.2147/DDDT.S483029. eCollection 2024.

Comparing Remimazolam and Propofol for Postoperative Anesthesia Satisfaction in Outpatient Gynecological Surgery: A Randomized Clinical Trial

Xu-Lin Wang #  1 , Ling-Ling Dai #  2 , Yan-Na Li  1 , Jian-Wen Zhang  1 , Ming-Cui Qu  1 , Yao-Yao Zhou  1 , Na Xing  1
Affiliations
Randomized Controlled Trial

Comparing Remimazolam and Propofol for Postoperative Anesthesia Satisfaction in Outpatient Gynecological Surgery: A Randomized Clinical Trial

Xu-Lin Wang et al. Drug Des Devel Ther. .

Abstract

Purpose: This study aimed to compare the efficacy of remimazolam and propofol regarding postoperative anesthesia satisfaction in patients undergoing outpatient gynecological surgery.

Patients and methods: This was a single-center, open-label, non-inferiority, randomized clinical trial. Patients aged ≥ 18 years who underwent outpatient gynecological surgery with sedation were enrolled. Participants were randomly assigned to be sedated with remimazolam or propofol. The primary endpoint was the immediate postoperative anesthesia satisfaction score, evaluated through the Iowa Satisfaction with Anesthesia Scale (ISAS).

Results: 168 patients were randomly allocated to either the remimazolam group (n = 84) or the propofol group (n = 84). The mean (standard deviation) ISAS scores immediately after surgery were 1.7 (0.6) for the remimazolam group and 2.0 (0.7) for the propofol group (difference, -0.2; 97.5% confidence interval [CI]: -0.5 to -0.0; p = 0.02), indicating non-inferiority. The length of post-anesthesia care unit (PACU) stay was longer in the remimazolam group than in the propofol group (27.6 [9.1] min vs 22.4 [7.0] min; difference, 5.2 [95% CI: 2.7 to 7.6] min; p < 0.001). High-intensity injection pain was less frequently observed in the remimazolam group than in the propofol group (3.6% vs 45.2%; difference, -41.7% [95% CI: -54.2% to -29.1%]; p < 0.001). The nausea score was higher in the remimazolam group immediately after surgery than in the propofol group. Pain, nausea, sleep quality, anxiety, and depression scores were higher in the remimazolam group than in the propofol group on postoperative day 1. The incidence of adverse events and other secondary endpoints was comparable between the two groups.

Conclusion: Remimazolam was non-inferior to propofol regarding postoperative anesthesia satisfaction in patients undergoing outpatient gynecological surgery. Therefore, it should be considered as a new sedation alternative in such procedures.

Keywords: outpatient gynecological surgery; patient satisfaction; propofol; remimazolam; sedation.

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Conflict of interest statement

The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Participant Flow.
Figure 2
Figure 2
The proportion of time spent on each MOAA/S score during sedation.
Figure 3
Figure 3
Primary outcome: mean (SD) ISAS scores immediately postoperatively in randomized and per-protocol populations, and subgroup analyses in the randomized population.
See this image and copyright information in PMC

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