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Brain Monitors to Reduce Child Confusion After Anesthesia
Sponsor: Baskent University
Summary
The goal of this clinical trial was to learn if using a brain monitor to adjust anesthesia (sleep medicine) during surgery could prevent emergence delirium (severe confusion and agitation upon waking) in children aged 2 to 12 years having their tonsils or adenoids removed. The main questions it aimed to answer were: Did using a brain monitor lower the chance of children waking up confused and upset? Did using the brain monitor reduce the amount of anesthesia gas (sevoflurane) needed during surgery, and did it affect recovery time or pain levels? Researchers compared anesthesia adjusted using a bispectral index (BIS) brain monitor to anesthesia adjusted using standard care to see if the brain monitor lowered the chance of emergence delirium. Participants in the study: Received general anesthesia (a standardized mix of inhaled and intravenous medicines, including sevoflurane and fentanyl) to safely sleep through surgery to remove their tonsils or adenoids Had the dose of their main anesthesia gas (sevoflurane) adjusted during surgery based on either brain monitor readings (targeting a specific sleep depth of 40-60) or standard physical responses (like heart rate and blood pressure) Were checked by the research team immediately after waking up to measure their confusion, agitation, and pain using standard clinical rating scales
Official title: The Role of BIS-Guided Anesthesia in Reducing Emergence Delirium in Children (Çocuklarda Derlenme Deliryumunun Azaltılmasında BİS Kılavuzluğunda Anestezi)
Key Details
Gender
All
Age Range
2 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
125
Start Date
2025-08-08
Completion Date
2025-11-21
Last Updated
2026-09-17
Healthy Volunteers
Yes
Conditions
Interventions
BIS-Guided Anesthesia
Anesthetic depth was continuously guided by the Bispectral Index (BIS) monitor. A single-use BIS sensor was placed on the patient's forehead before anesthesia induction to record real-time EEG activity. The primary inhaled anesthetic (sevoflurane) was continuously titrated throughout the surgery to strictly maintain a BIS value within the target range of 40 to 60. If the BIS value dropped below 40, the sevoflurane concentration was decreased. If the BIS value exceeded 60, the continuous remifentanil infusion (0.02-0.1 mcg/kg/min) was increased first, followed by an increase in sevoflurane if necessary. Intervention
Standard Care Anesthesia
Anesthetic depth was guided solely by traditional clinical signs and autonomic responses. The primary inhaled anesthetic (sevoflurane) was initiated at a 1% end-tidal concentration and adjusted in 0.25% increments (range 0.50% to 1.5%) to maintain the patient's heart rate and blood pressure within ±25% of their baseline pre-anesthesia values. Remifentanil was also infused continuously (0.02-0.1 mcg/kg/min) and adjusted based on clinical requirements. A BIS sensor was attached to the patient to record data, but the monitor screen was completely blinded to the anesthesia care provider, ensuring titration relied exclusively on standard hemodynamic metrics.
Locations (1)
Baskent University
Ankara, Turkey (Türkiye)