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End-of-Surgery Remimazolam Bolus Cuts Emergence Delirium Incidence by 92% in Children
A single intravenous dose of remimazolam 0.1 mg/kg given at the conclusion of sevoflurane anesthesia reduced emergence delirium incidence from 20.8% to 1.8% compared with placebo — representing approximately a 92% lower relative risk (RR 0.08, 95% CI 0.01–0.63; p = 0.002) and an absolute risk reduction of 19.0 percentage points (95% CI 7.5–31.8). Critically, this benefit was achieved without any prolongation of the time to emergence or delay in early postoperative recovery.
What Was Studied
This trial investigated whether a single bolus of remimazolam — an ultra-short-acting benzodiazepine — administered immediately after sevoflurane discontinuation and before extubation could reduce the incidence of emergence delirium (ED) in pediatric patients recovering from tonsillectomy and/or adenoidectomy. ED, defined here as a Pediatric Anesthesia Emergence Delirium (PAED) score of 10 or greater at extubation, is a recognized complication of sevoflurane-based anesthesia in young children undergoing otolaryngologic procedures.
How It Was Studied
This was a prospective, randomized, triple-blind, placebo-controlled trial enrolling 110 children between the ages of 3 and 9 years, all classified as American Society of Anesthesiologists (ASA) physical status I, who were undergoing tonsillectomy and/or adenoidectomy under sevoflurane anesthesia. Participants were randomly assigned to receive either remimazolam 0.1 mg/kg intravenously (n = 57) or an equivalent volume of normal saline as placebo (n = 53) at the moment sevoflurane was discontinued, prior to extubation. Secondary outcomes captured pain behavior via FLACC scores, time to emergence, achievement of an early recovery threshold (modified Aldrete score greater than 8), incidence of postoperative vomiting through 30 minutes, and airway complications. The triple-blind design minimized assessment bias across patients, caregivers, and outcome evaluators.
What Was Observed
- Emergence delirium was substantially reduced in the remimazolam group: only 1 of 57 children (1.8%) met the PAED threshold for ED, compared with 11 of 53 children (20.8%) in the placebo group. This translates to approximately 92% lower relative risk (RR 0.08, 95% CI 0.01–0.63), with a number needed to treat of just 6, indicating a clinically meaningful effect.
- Pain-related behavioral scores favored remimazolam at extubation: the overall distribution of FLACC scores differed significantly between groups, with FLACC scores of 0 — indicating no observable pain or distress behavior — occurring more frequently in the remimazolam arm (p = 0.047).
- Emergence timing and early recovery were equivalent across groups: median time to emergence was 10 minutes in both the remimazolam and placebo groups, and all enrolled children achieved a modified Aldrete score above 8 within 15 minutes, indicating no sedation-related delay attributable to the intervention.
- Safety outcomes showed no significant between-group differences: postoperative vomiting assessed at 5 minutes and through 30 minutes did not differ significantly between groups, and airway complication rates were comparable, supporting an acceptable short-term safety profile for this dosing strategy.
Why This Matters
Emergence delirium is described in this study as a common complication of sevoflurane anesthesia in children undergoing otolaryngologic surgery, and the placebo arm’s 20.8% incidence confirms this as a clinically frequent event in the target population. The finding that a single, precisely timed pharmacological intervention can reduce this burden by approximately 19 absolute percentage points — without compromising the speed or quality of early recovery — identifies end-of-surgery remimazolam as a potentially actionable addition to pediatric anesthetic management protocols for this procedure type.
How to Read This Result
While this randomized, triple-blind trial shows a robust and statistically significant effect with a clinically meaningful NNT of 6, the single-institution design and restriction to otherwise healthy ASA I children mean that generalizability to broader or more complex pediatric populations requires further investigation.
Limitations
The abstract does not explicitly report study limitations.