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Randomized Controlled Trial
. 2022 Sep 30:16:3413-3420.
doi: 10.2147/DDDT.S381611. eCollection 2022.

Remimazolam for the Prevention of Emergence Delirium in Children Following Tonsillectomy and Adenoidectomy Under Sevoflurane Anesthesia: A Randomized Controlled Study

Xue Yang #  1 , Chuantao Lin #  2 , Sisi Chen  3 , Yuezhou Huang  3 , Qiong Cheng  1 , Yusheng Yao  3
Affiliations
Randomized Controlled Trial

Remimazolam for the Prevention of Emergence Delirium in Children Following Tonsillectomy and Adenoidectomy Under Sevoflurane Anesthesia: A Randomized Controlled Study

Xue Yang et al. Drug Des Devel Ther. .

Abstract

Purpose: To identify the effectiveness of remimazolam at the end of tonsillectomy and adenoidectomy for preventing emergence delirium in children under sevoflurane anesthesia.

Patients and methods: One hundred and four patients aged 3-7 years scheduled for tonsillectomy and adenoidectomy under sevoflurane anesthesia were recruited. Patients were randomly assigned to receive either remimazolam 0.2 mg kg-1 (intervention, n=52) or 0.9% normal saline (control, n=52) at the end of the procedure. The primary outcome was the incidence of emergence delirium, defined as a Pediatric Anesthesia Emergence Delirium (PAED) score ≥10. Secondary outcomes were peak PAED score, emergence time, postoperative pain intensity, length of postanesthesia care unit (PACU) stay, parental satisfaction, and postoperative behavior changes three days postoperatively.

Results: Emergence delirium occurred in 6 of 51 (12%) patients receiving remimazolam versus 22 of 50 (44%) patients receiving saline (risk difference 32% [95% confidence interval, 16% to 49%], relative risk 0.27 [95% confidence interval, 0.12 to 0.60]; P<0.001). The peak PAED scores (median [interquartile range]) were lower in the remimazolam group than in the saline group (7 [6-8] versus 9 [8-11], P<0.001). Likewise, parental satisfaction was improved in the remimazolam group compared with the saline group (9 [8-10] versus 8 [7-8], P<0.001). There was no difference between groups concerning postoperative pain scores, length of PACU stay, or postoperative behavior changes.

Conclusion: In children undergoing tonsillectomy and adenoidectomy, administration of remimazolam 0.2 mg kg-1 at the end of the surgery, compared with 0.9% saline, resulted in a significantly lower likelihood of emergence delirium after sevoflurane anesthesia.

Keywords: emergence delirium; general anesthesia; pediatric anesthesia; remimazolam.

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Conflict of interest statement

The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials (CONSORT) flow diagram. Adapted from Schulz K, Altman D, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. BMJ. 2010;340:c332.
Figure 2
Figure 2
The peak PAED scores and the incidence of ED during the first 30 min in the postanesthesia care unit.
See this image and copyright information in PMC

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