EEG-Guided Titration of Sevoflurane and Pediatric Anesthesia Emergence Delirium: A Randomized Clinical Trial.

IMPORTANCE

Pediatric anesthesia emergence delirium (PAED) is a common complication of general anesthesia and has unknown etiology. Exposure to volatile anesthetics may contribute to PAED, and excessive exposure may occur frequently during routine pediatric anesthesia.

OBJECTIVE

To examine whether use of electroencephalography (EEG) monitoring can reduce PAED by minimizing exposure to sevoflurane while maintaining a state of unconsciousness under anesthesia.

DESIGN, SETTING, AND PARTICIPANTS: A single-center, parallel-group, 2-arm, superiority randomized clinical trial with a 1:1 allocation ratio was conducted from October 13, 2021, to March 18, 2023, at an academic tertiary pediatric hospital in Japan. The follow-up period was 24 ± 6 hours postoperatively or uneventful discharge to home, whichever came first. The observer for the primary outcome was blinded to patient assignment. The trial included a convenience sample of children aged 1 to younger than 6 years undergoing general anesthesia for procedures for which reliable antinociception can be provided. Data analysis was performed in March 2023.

INTERVENTION

EEG-guided titration of anesthesia to minimize sevoflurane exposure (EEG-guided group) vs standard 1.0-minimum alveolar concentration (MAC) sevoflurane anesthesia (control group).

MAIN OUTCOMES AND MEASURES

Proportion of patients who developed PAED, defined by a maximum PAED score of 10 or higher.

RESULTS

Of the 177 participants who completed follow-up, 125 (71%) were male and 52 (29%) were female. The EEG-guided group included 91 participants (mean [SD] age, 2.9 [1.5] years), and the control group included 86 participants (mean [SD] age, 2.8 [1.6] years). In the EEG-guided group, sevoflurane exposure was reduced by 1.4 MAC-hours (96.65% CI, 1.1 to 1.6 MAC-hours). A total of 30 (35%) in the control group and 19 (21%) in the EEG-guided group developed PAED (difference, 14%; 96.65% CI, -0.0019% to 28%; 95% CI, 0.92% to 27%; P = .04). Children in the EEG-guided group emerged a mean of 21.4 minutes (96.65% CI, 15.4 to 27.4 minutes) earlier from general anesthesia and spent a mean of 16.5 minutes less (96.65% CI, 10.8 to 22.3 minutes less) in the postanesthesia care unit.

CONCLUSIONS AND RELEVANCE

EEG-guided management of general anesthesia reduced sevoflurane exposure and pediatric anesthesia emergence delirium in children, with faster emergence and shorter postanesthesia care unit stays. The findings suggest that high concentrations of sevoflurane for induction followed by routine use of 1.0-MAC sevoflurane for maintenance may be excessive.

TRIAL REGISTRATION

Japan Registry of Clinical Trials Identifier: jRCTs032210248.