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Brain Monitors to Reduce Child Confusion After Anesthesia

StatusCompleted
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
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
Trial Details
NCT Number NCT07826559
Lead Sponsor Baskent University
Conditions
(from sponsor)
Emergence Delirium (Derlenme Deliryumu)
Related terms Emergence Delirium
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov