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A randomized controlled study of remimazolam in preschool children undergoing adenotonsillectomy
Yong Wu1, Fenjun Wang2, Kai Zhu3
1Department of ENT, Jiaxing Hospital of Traditional Chinese Medicine, Jiaxing University, Jiaxing, China.
Insights
Remimazolam, used for general anesthesia in preschool children undergoing adenotonsillectomy, resulted in faster extubation and awakening times. It also significantly reduced emergence agitation, hypotension, and injection site pain compared to propofol.
Area of Science:
- Anesthesiology
- Pediatric Surgery
- Pharmacology
Background:
- Remimazolam is increasingly used for general anesthesia.
- Limited data exists on its use in preschool children.
- Adenotonsillectomy is a common procedure in this age group.
Purpose of the Study:
- To evaluate the efficacy and safety of remimazolam compared to propofol in preschool children undergoing adenotonsillectomy.
- To assess the impact of remimazolam on emergence agitation and adverse events.
Main Methods:
- A randomized controlled trial involving 100 preschool children undergoing adenotonsillectomy.
- Participants were divided into two groups: remimazolam and propofol for anesthesia induction and maintenance.
- Key outcomes included onset time, extubation time, awakening time, and incidence of adverse events.
Main Results:
- Remimazolam showed a longer onset time but significantly shorter extubation and awakening times compared to propofol.
- The incidence of emergence agitation was lower in the remimazolam group (12% vs. 30%).
- Remimazolam also reduced hypotension (26% vs. 48%) and injection site pain (4% vs. 48%).
Conclusions:
- Remimazolam is a viable anesthetic option for preschool children undergoing adenotonsillectomy.
- It offers benefits of faster recovery and reduced adverse events like emergence agitation and pain.
- Further research may explore optimal dosing and long-term effects.
Background:
At present, remimazolam is widely used for general anesthesia. However, the literature on the usability of remimazolam is limited in preschool children. This study aimed to explore effects of remimazolam on emergence agitation and adverse events in preschool children undergoing adenotonsillectomy.
Methods:
A total of 100 children undergoing adenotonsillectomy, randomly divided into the Remimazolam group and the Propofol group, with 50 cases in each group. The Remimazolam group received remimazolam for the induction and maintenance of general anesthesia, and the Propofol group received propofol for the induction and maintenance of general anesthesia. The onset time, extubation time and awakening time were recorded. Systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured before anesthesia (T0), immediately before intubation (T1), 3 min after intubation (T2), 15 min after the start of the surgery (T4) and at the end of the surgery (T5). The drug-related complications including hypotension, bradycardia, injection site pain, respiratory depression, emergence agitation, nausea and vomiting were recorded.
Results:
The onset time was significantly longer in the Remimazolam group (64.3 ± 8.1 vs. 38.3 ± 4.5 s, P < 0.001), while the extubation time and awakening time were shorter in the Remimazolam group than the Propofol group (12.9 ± 2.2 vs. 14.5 ± 3.2 min, P = 0.005; 19.9 ± 4.7 vs. 21.8 ± 4.5 min, P = 0.039, respectively). The incidence of emergence agitation, hypotension and injection site pain was lower in the Remimazolam group than the Propofol group (12% vs. 30%, P = 0.027; 26% vs. 48%, P = 0.023; 4% vs. 48%, P < 0.001, respectively).
Conclusion:
This study demonstrated that remimazolam not only shortened extubation and awakening times but also reduced the incidence of emergence agitation, hypotension, and injection site pain in preschool children undergoing adenotonsillectomy compared with propofol.
Clinical Trial Registration:
https://www.chitr.org.com, identifier: ChiCTR240085456.
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