Impact of Neuromonitoring on Postoperative Agitation in Pediatric General Anesthesia

NCT07243990 | Not Yet Recruiting

• 1 other identifier: 2025-SEAH-ETO-DSA
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Agitation; Emergence Delirium, Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Group Monitoring-Based Care

EXPERIMENTAL

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

Group Standart Care

EXPERIMENTAL

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

Interventions

dsa intervention group DEVICE

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.

Group Monitoring-Based Care

Traditional Monitoring OTHER

This group will receive anesthesia induction using the traditional method, and monitoring will continue simultaneously with EEG (Electroencephalography).

Group Standart Care

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 6-12 years
• Without chronic comorbid conditions
• No history of epilepsy
• Presenting for surgery with preserved consciousness, oriented and cooperative

You may not qualify if:

• Intracranial surgeries
• Intellectual disability
• Emergency trauma cases
• Forehead area unsuitable for electrode placement

Sponsors & Collaborators

• Sakarya University: lead

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: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Specialist

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: December 30, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-08