NCT05906225

Anesthesia and EEG Discontinuity in Infants

The Impact of Electroencephalogram (EEG) - Guided Inhalational Anesthetic Control on the Occurrence of EEG Discontinuity in Infants: A Prospective Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

Summary

This study is a randomized controlled trial to evaluate whether EEG-guided calibration of inhalation agents can reduce occurrence of EEG discontinuity in infants during general anesthesia.

Detailed description

This is a study for comparison of incidence of EEG discontinuity during general anesthesia using sevoflurane. EEG guidance group will receive calibration of fraction of inhalational sevoflurane according to components of slow wave and delta wave of raw EEG. Control group will receive conventional management of anesthesia according to vital signs.

Conditions

• Anesthesia, General
• Electroencephalography
• Infant
• Anesthesia, Inhalation

Interventions

Type	Name	Description
PROCEDURE	EEG guided anesthesia	Monitoring of electroencephalogram via Sedline probe by MASIMO corporation. Adjust concentration of inhalational sevoflurane during anesthesia, according to component of slow\&delta wave and alpha wave, so that slow/delta oscillation (with or without alpha oscillation) is maintained.
PROCEDURE	Conventional anesthesia	Adjust concentration of inhalational sevoflurane during anesthesia, according to vital signs, so that mean blood pressure and heart rate are maintained between 80% and 120% of baseline values measured at ward before anesthesia.

Timeline

• Start date: 2023-06-20
• Primary completion: 2025-03-30
• Completion: 2025-05-30
• First posted: 2023-06-15
• Last updated: 2023-06-15

Locations

1 site across 1 country: South Korea