Brain Monitors to Reduce Child Confusion After Anesthesia

NCT07826559 | Completed

• 1 other identifier: KA24/328
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Emergence Delirium (Derlenme Deliryumu)

Keywords

emergence delirium; pediatric anesthesia; bispectral index; anesthetic depth; adenoidectomy; tonsillectomy

Outcome Measures

Primary Outcomes (3)

• Primary Outcome Measure 1: Incidence of Emergence Delirium Assessed by the PAED Scale

  Evaluated postoperatively using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale ranges from a minimum of 0 to a maximum of 20. Higher scores mean a worse outcome (more severe delirium). Scores of 10 or higher were classified as a positive diagnosis for emergence delirium.

  Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.

• Primary Outcome Measure 2: Incidence of Emergence Delirium Assessed by the Watcha Scale

  Evaluated postoperatively using the Watcha behavioral scale. The scale ranges from a minimum of 1 to a maximum of 4. Higher scores mean a worse outcome (greater agitation and delirium). Scores of 3 to 4 were classified as a positive diagnosis for emergence delirium.

  Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.

• Primary Outcome Measure 3: Incidence of Emergence Delirium Assessed by the Cravero Scale

  Evaluated postoperatively using the Cravero behavioral scale. The scale ranges from a minimum of 1 to a maximum of 5. Higher scores mean a worse outcome (greater agitation). Scores of 4 or higher were classified as a positive diagnosis for emergence delirium.

  Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.

Secondary Outcomes (4)

• Total Sevoflurane Consumption

  Intraoperative (From anesthesia induction until the completion of surgery).

• Postoperative Pain Assessed by the FLACC Scale

  Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.

• Rescue Opioid Usage

  Up to 60 minutes during the post-anesthesia recovery period.

• Recovery Time

  Up to 4 hours (From transfer to the recovery unit until discharge criteria were successfully met).

Study Arms (2)

BIS-Guided Anesthesia

EXPERIMENTAL

This group received the specific intervention (the BIS monitor to guide anesthesia depth) that is the main focus of your research study.

Device: BIS-Guided Anesthesia

Standard Care Anesthesia

ACTIVE COMPARATOR

This group received the standard, established method of care (titrating anesthesia based on heart rate and blood pressure).

Drug: Standard Care Anesthesia

Interventions

BIS-Guided Anesthesia DEVICE

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

BIS-Guided Anesthesia

Standard Care Anesthesia DRUG

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.

Standard Care Anesthesia

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 2 and 12 years
• Scheduled for a planned surgery to remove adenoids, tonsils, or both
• Generally healthy or having only mild medical conditions (American Society of Anesthesiologists class I or II)
• Expected to have a surgery that lasts less than 4 hours
• Having the procedure as an outpatient and expected to go home the same day

You may not qualify if:

• Having severe medical conditions (American Society of Anesthesiologists class III or IV)
• Having a known history of neurological or psychiatric diseases
• Diagnosed with a developmental delay
• Having severe heart, lung, or metabolic conditions
• Having a known allergy to any of the medications used in the study
• Parents or legal guardians refuse to provide written consent to participate

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This was a single-blind clinical trial. Participants and their guardians were masked to the study arm assignment. Anesthesia care providers could not be masked to the intervention assignment itself, as they were required to actively titrate the anesthesia based on the assigned method. However, a specific masking protocol was used for the active comparator group to prevent bias. In the standard care group, the BIS monitor was applied to the patient to record data, but the screen was completely covered. This ensured the care provider remained masked to the actual BIS values during the surgery, forcing them to rely solely on standard hemodynamic-guided titration.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study utilized a parallel assignment model. A total of 125 pediatric patients (aged 2 to 12 years) undergoing adenoidectomy and/or tonsillectomy were randomized in a 1:1 ratio into two distinct, simultaneous arms: the intervention group (BIS-guided anesthesia) and the active comparator group (standard care). During the intraoperative phase, both groups received identical anesthetic agents (sevoflurane and remifentanil). The fundamental difference between the parallel arms was the titration strategy. In the BIS arm, sevoflurane was titrated continuously to maintain a strict Bispectral Index target of 40-60. In the standard-care arm, anesthesiologists adjusted the sevoflurane dosage based entirely on traditional clinical and hemodynamic responses, such as heart rate and blood pressure. Participants remained in their initially assigned arms for the entire duration of the surgery and the postoperative recovery observation period. No crossover design was utilized.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: September 17, 2026
• Study Start: August 8, 2025
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

TU (1)