臨床研究等提出・公開システム

Titration of Volatile Anesthetic with Brain Function Monitoring for Prevention of Pediatric Anesthesia Emergence Delirium: A Randomized Controlled Trial

Titration of Volatile Anesthetic with Brain Function Monitoring for Prevention of Pediatric Anesthesia Emergence Delirium: A Randomized Controlled Trial

177

Scheduled surgical procedure under general anesthesia for more than 30 minutes Age 1 to 6 Procedure with minimal or easily controlled postoperative pain

218 potentially eligible patients were approached by the study team 18 declined to participate 200 underwent randomization 22 were excluded acter randomization (1 withdrew consent, 1 met exclusion criteria, 4 postponed or cancelled their surgery, 16 because the study team was not available) 91 received EEG-guided sevoflurane anesthesia From the EEG group, 91 were included in analysis of the primary outcome (PAED Score) 87 received standard sevoflurane anesthesia From the Control group, 1 was excluded after assignment due to an adverse event (laryngospasm) From the Control group,86 were included in analysis of the primary outcome (PAED Score)

One case of laryngospasm in Control group resulting in extension of inpatient stay

PAED score >= 10 Control:30/86 35% vs EEG:19/91 21%, p=0.037. Maximum PAED score Control:4.9(+/-)5.9 vs EEG:6.3(+/-)5.8, p=0.124. Maximum SEV% Control:5.0(+/-)0.0% vs EEG:2.0(+/-)0.2%, p<0.001. Maintenance SEV% Control:2.5(+/-)0.0% vs EEG:0.9(+/-)0.2%, p<0.001. SEV exposure Control:2.1(+/-)1.1 vs EEG:0.8(+/-)0.5 MAC-hours, p<0.001. Emergence Control:40.3(+/-)21.4min vs EEG:19.0(+/-)15.7min, p<0.001. PACU stay Control:34.3(+/-)19.8min vs EEG:17.8(+/-)15.3min, p<0.001.

EEG-guided titration of anesthesia greatly reduced exposure to sevoflurane, leading to a reduced incidence of PAED, shorter recovery times and reduced length of stay in the PACU.

June. 08, 2023

Yes

Deidentified patient data will be included in submissions to scientific journals and be made public.

https://jrct.mhlw.go.jp/latest-detail/jRCTs032210248

Kasuya Shugo

National Center for Child Health and Development

2-10-1 Okura, Setagaya-ku

kasuya-s@ncchd.go.jp

Miyasaka Kiyoyuki

National Center for Child Health and Development

2-10-1 Okura, Setagaya-ku

+81-3-3416-0181

miyasaka-k@ncchd.go.jp

Complete

Aug. 17, 2021

Interventional

randomized controlled trial

single blind

active control

single assignment

prevention purpose

Scheduled surgical procedure under general anesthesia for more than 30 minutes
Age 1 to 6
Procedure with minimal or easilly controlled postoperative pain

Unable to place EEG sensor (e.g. abnormal skin, interference with surgical field)
Neurological condition affecting evaluation of EEG or mental state
Exclusion by discretion of anesthesiologist

Both

General Anesthesia

Titration of anesthetic by brain function monitoring

Electroencephalography

Anesthesia, General

Electroencephalography

Pediatric Anesthesia Emergence Delirium (PAED) Score

Amount of exposure to anesthetic agent

+81-3-3416-0181

July. 29, 2021

none