Effects of intraoperative low-dose remimazolam maintenance on emergence agitation and emergence time in patients undergoing oral surgery: protocol for a randomized controlled trial.

Authors

Xiaoxuan Hu, Chong Fu, Guorong Bi, Qiyun Tan, Yaoyu Ying, Weiming Zhao, Xuechun Cai, Nan Yin, Xin Wang, Hong Liu, Lingzhong Meng, Fu-Hai Ji, Qiang Sun, Baojian Zhao, Huayue Liu

Published in

Annals of medicine. Volume 58. Issue 1. Pages 2700794. Epub Jul 11, 2026.

Abstract

Emergence agitation (EA) is a clinically significant complication during early recovery from general anesthesia. This protocol describes a randomized controlled trial designed to determine whether intraoperative low-dose remimazolam maintenance reduces the incidence of EA without prolonging emergence time in patients undergoing oral surgery.
This multicenter, randomized, controlled clinical trial will enroll 388 patients scheduled for oral surgery under general anesthesia. Patients will be randomly allocated in a 1:1 ratio to either the remimazolam group, receiving a low-dose intraoperative infusion of remimazolam, or the control group, receiving an equivalent volume of normal saline. The primary outcome is the incidence of emergence agitation; the key secondary outcome is emergence time. Emergence time will be evaluated within a non-inferiority framework, whereas the incidence of emergence agitation will be tested for superiority. Additional endpoints comprise pain scores, analgesic use, the rate of postoperative nausea and vomiting (PONV), recourse to rescue antiemetics, the occurrence of postoperative sleep disturbance (PSD), time spent in the post-anesthesia care unit (PACU), postoperative hospital length of stay, overall recovery quality, the frequency of perioperative adverse events, and patient satisfaction.
This trial will investigate the efficacy and safety of intraoperative low-dose remimazolam maintenance in patients undergoing oral surgery. The findings may provide evidence supporting a practical pharmacological intervention to reduce EA and enhance postoperative recovery.
Chinese Clinical Trial Registry (ChiCTR2600116544).

PMID:
42433169
Bibliographic data and abstract were imported from PubMed on 11 Jul 2026.

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