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Effect of Remimazolam on Emergence Delirium in Children Undergoing Laparoscopic Surgery: A Double-blinded Randomized
Yu-Hang Cai1, John Wei Zhong2, Hong-Yu Ma1
1Department of Anesthesiology and Perioperative Medicine, Second Affiliated Hospital and Yuying Children's Hospital, Key Laboratory of Pediatric Anesthesiology, Ministry of Education, and Key Laboratory of Anesthesiology of Zhejiang Province, Wenzhou Medical University, Wenzhou, China.
Insights
Remimazolam effectively prevents emergence delirium in children undergoing anesthesia. Both continuous infusion and single bolus administration significantly reduced delirium incidence and the need for rescue propofol.
Area of Science:
- Pediatric Anesthesia
- Pharmacology
- Clinical Trials
Background:
- Emergence delirium is a common concern in pediatric anesthesia, with no established prevention methods.
- This study aimed to evaluate remimazolam's efficacy in preventing emergence delirium in pediatric patients.
Purpose of the Study:
- To investigate the hypothesis that remimazolam, administered as a continuous infusion or single bolus, reduces emergence delirium in children.
- To compare the incidence of emergence delirium and need for rescue propofol between remimazolam groups and a control group.
Main Methods:
- 120 children (1-6 years) were randomized into three groups: continuous remimazolam infusion (RC), single bolus remimazolam (RB), and saline control (C).
- The primary outcome was emergence delirium incidence, assessed using the Pediatric Anesthesia Emergence Delirium scale.
- Secondary outcomes included rescue propofol, recovery time, and adverse events.
Main Results:
- Remimazolam significantly reduced emergence delirium incidence: 5% in RC and 7.7% in RB, versus 35% in C (P < 0.003).
- Fewer patients required rescue propofol in the remimazolam groups (5% RC, 7.7% RB) compared to control (25%) (P < 0.014).
- No significant differences were observed in recovery time or adverse events between groups.
Conclusions:
- Both continuous infusion and single bolus remimazolam are effective in preventing emergence delirium in children.
- Remimazolam administration offers a promising strategy to improve pediatric anesthesia outcomes by reducing emergence delirium.
Background:
Preventing emergence delirium is a clinical goal for pediatric anesthesia, yet there is no consensus on its prevention. This study investigated the hypothesis that a continuous infusion or a single bolus of remimazolam can reduce the incidence of emergence delirium in children.
Methods:
A total of 120 children aged 1 to 6 yr were randomly and equally allocated into three groups: group RC, which received a continuous infusion of remimazolam at 1 mg · kg-1 · h-1; group RB, which received a single bolus of remimazolam at 0.2 mg · kg-1 at the beginning of wound closure; and group C, which received a continuous infusion of saline at 1 ml · kg-1 · h-1 and a single bolus of saline at 0.2 ml · kg-1 at the beginning of sutures. The primary outcome was the incidence of emergence delirium assessed by the Pediatric Anesthesia Emergence Delirium scale. Secondary outcomes included the number of rescue propofol administrations in the postanesthesia care unit, recovery time, and adverse events.
Results:
Emergence delirium was observed in 14 of 40 (35%) patients in group C, 2 of 40 (5%) patients in group RC (vs. group C, P = 0.001; risk ratio, 95% CI: 0.14, 0.04 to 0.59), and 3 of 39 (7.7%) patients in group RB (vs. group C, P = 0.003; risk ratio, 95% CI: 0.22, 0.07 to 0.71). Ten of 40 patients in group C, 2 of 40 patients in group RC (vs. group C, P = 0.012; risk ratio, 95% CI: 0.20, 0.05 to 0.86), and 2 of 39 patients in group RB (vs. group C, P = 0.014; risk ratio, 95% CI: 0.21, 0.05 to 0.88) needed rescue propofol. No differences in the recovery time and adverse effects were detected.
Conclusions:
Both continuous infusion and single bolus administration of remimazolam can effectively reduce the occurrence of emergence delirium in children.
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