UC Davis

Introduction

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.

Patients and methods

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.

Discussion

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.

Trial registration

Chinese Clinical Trial Registry (ChiCTR2600116544).