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

TL;DR

This randomized controlled trial (n=388) investigates whether low-dose intraoperative remimazolam reduces emergence agitation without prolonging emergence time in oral surgery patients. The study tests remimazolam superiority for agitation prevention and non-inferiority for emergence time, with secondary outcomes including pain, PONV, postoperative sleep disturbance, and recovery quality.

Key findings

• Primary outcome: incidence of emergence agitation (tested for superiority in remimazolam vs. saline control)
• Key secondary outcome: emergence time (tested for non-inferiority)
• Additional endpoints include pain scores, PONV rates, postoperative sleep disturbance, PACU stay duration, and patient satisfaction
• Multicenter design with 1:1 randomization to low-dose intraoperative remimazolam or normal saline control

Why this matters at the bedside

Emergence agitation is a clinically significant complication during early recovery from general anesthesia. If remimazolam proves effective at reducing EA without delaying emergence, it could provide a practical pharmacological strategy to improve postoperative recovery quality in oral surgery patients.