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Protocol for a randomized controlled trial to reduce pediatric anesthesia emergence delirium by titration of
Yasuyuki Suzuki1,2, Kiyoyuki W Miyasaka3,4,5, Kuniyoshi Hayashi6
1National Center for Child Health and Development, Tokyo, Japan.
Insights
This study investigates reducing pediatric anesthesia emergence delirium (PAED) by using brain function monitoring to guide anesthetic levels. EEG-guided anesthesia may lower sevoflurane exposure and prevent PAED in young children.
Area of Science:
- Anesthesiology
- Pediatric Medicine
- Neuroscience
Background:
- Pediatric anesthesia emergence delirium (PAED) is a common complication in children undergoing anesthesia.
- PAED affects up to 30% of children aged 1-6 years and its etiology is not fully understood.
- Anesthetic agent exposure, particularly volatile anesthetics like sevoflurane, is hypothesized to contribute to PAED.
Purpose of the Study:
- To evaluate if electroencephalography (EEG)-guided anesthesia can reduce the incidence of PAED in pediatric patients.
- To compare standard sevoflurane anesthesia with EEG-guided anesthesia in terms of PAED incidence.
- To determine if minimizing sevoflurane exposure through EEG monitoring prevents PAED.
Main Methods:
- A superiority trial comparing standard anesthesia (1.0 MAC sevoflurane) with EEG-guided anesthesia (minimum concentration for surgical anesthesia).
- 90 children aged 1-6 years undergoing minimally painful procedures were randomized to each group.
- PAED scores were assessed by a blinded observer in the post-anesthesia care unit (PACU).
Main Results:
- EEG-guided anesthesia is expected to reduce sevoflurane exposure.
- This reduction in anesthetic exposure is anticipated to decrease the incidence of PAED.
- Standard anesthetic levels (1.0 MAC sevoflurane) may be excessive and linked to PAED.
Conclusions:
- Proactive use of brain function monitoring (EEG) can optimize anesthetic management in children.
- EEG-guided anesthesia is a promising strategy to prevent PAED by minimizing volatile anesthetic exposure.
- This approach may reduce adverse outcomes associated with excessive anesthesia in pediatric patients.
Background:
Emergence agitation or emergence delirium is a common complication of unknown etiology in pediatric anesthesia. Pediatric anesthesia emergence delirium (PAED) has been reported most commonly in younger children and may occur in about 30% of children up to 5-6 years old. Exposure to anesthetic agents may contribute to PAED, and we hypothesized that a management strategy to minimize exposure to volatile anesthetics may reduce PAED. Electroencephalography (EEG) signatures captured and displayed by brain function monitors during anesthesia change with concentration of sevoflurane and level of unconsciousness, and these EEG signatures may be used to inform titration of anesthetics.
Methods:
A single-center, parallel-group, two-arm, superiority trial with a 1:1 allocation ratio will be performed to compare the incidence of PAED following standard sevoflurane anesthesia (maintained at 1.0MAC) and EEG-guided anesthesia (minimum concentration to sustain surgical anesthesia as determined by monitoring of EEG signatures). Participants between 1 and 6 years of age undergoing surgical procedures involving minimal postoperative pain will be randomly assigned to receive standard (n = 90) or EEG-guided (n = 90) anesthesia. PAED score will be assessed by a blinded observer in the PACU on arrival and after 5, 10, 15, and 30 min.
Discussion:
Anesthesia management with proactive use of brain function monitoring is expected to reduce exposure to sevoflurane without compromising surgical anesthesia. We expect this reduced exposure should help prevent PAED. Routinely administering what may be considered standard levels of anesthetic such as 1.0 MAC sevoflurane may be excessive and potentially associated with unfavorable sequelae such as PAED.
Trial Registration:
Japan Registry of Clinical Trials (jRCT) jRCTs032210248. Prospectively registered on 17 August 2021.
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