Impact of Neuromonitoring on Postoperative Agitation in Pediatric General Anesthesia

The Effect of Neuromonitoring on the Incidence of Postoperative Agitation in Pediatric Patients Undergoing General Anesthesia

Postoperative agitation is frequently observed in the pediatric patient group following general anesthesia. The exact cause of this agitation has not been clearly determined; however, it may be associated with various factors such as anesthesia depth, family approach, postoperative pain, or unpleasant odors perceived by the child. The depth of anesthesia is indirectly monitored by observing the patient's blood pressure, heart rate, and oxygen saturation, as well as by assessing the alveolar concentration of the inhalation agent. Patients under anesthesia are in a state of deep sleep. In recent years, this sleep state has begun to be monitored more closely with the development of new devices.

Electroencephalography (EEG) is a test that records and measures the brain's electrical activity, providing information about the depth of sleep according to the patient's brain activity. The Density Spectral Array (DSA) device, developed for use in operating rooms, facilitates the interpretation of EEG data and guides the anesthesiologist. In our operating room, patients under anesthesia are also monitored using this device.

Our aim is to evaluate emergence agitation in patients monitored with this device compared to those who are not monitored.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Agitation; Emergence Delirium, Anesthesia
• Intervention / Treatment: Device: dsa intervention group; Other: Traditional Monitoring

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients aged 6-12 years

Without chronic comorbid conditions

No history of epilepsy

Presenting for surgery with preserved consciousness, oriented and cooperative

Exclusion Criteria:

Intracranial surgeries

Intellectual disability

Emergency trauma cases

Forehead area unsuitable for electrode placement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Monitoring-Based Care; After the patients are taken into the operating room, they will be monitored. This monitoring will include tracking brain activity using DSA (Depth of Sedation Assessment), and anesthesia induction will be performed under this monitoring.	Device: dsa intervention group; The Density Spectral Array (DSA) device, developed for use in operating rooms, facilitates the interpretation of Electroencephalogram (EEG) data and guides the anesthesiologist. In our operating room, patients under anesthesia are also monitored using this device.
Experimental: Group Standart Care; After the patients are taken into the operating room, they will be monitored, and anesthesia induction will be performed using the traditional method by administering anesthetic agents based on body weight.	Other: Traditional Monitoring; This group will receive anesthesia induction using the traditional method, and monitoring will continue simultaneously with EEG (Electroencephalography).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative agitation after postoperative 30 minutes	Richmond Agitation-Sedation Scale (RASS) (-5 to +4) will be recorded at 0, 5, 10, 15, and 30 minutes after emergence in the postoeperative care unit. For each participant, the highest (maximum) RASS value observed within the first 30 minutes will be analyzed as the primary outcome. Higher scores indicate more severe agitation. The Richmond Agitation-Sedation Scale (RASS) is used to assess a patient's level of agitation or sedation. Scores range from +4 to -5, where +4 represents the most severe agitation and -5 represents unarousable sedation. Higher positive scores indicate more severe agitation, while lower negative scores indicate deeper sedation.	First 30 minutes in the postoperative care unit after emergence from anesthesia.

Collaborators and Investigators

• Sponsor: Sakarya University

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: 2025-SEAH-ETO-DSA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No