Ireland
--:--IST
Recruiting Not applicable

Impact of Neuromonitoring on Postoperative Agitation in Pediatric General Anesthesia

NCT07243990 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-09-04
Last updated
2026-09-09

Condition(s) studied

Postoperative AgitationEmergence Delirium, Anesthesia

Investigational drug(s) / intervention(s)

dsa intervention groupTraditional Monitoring

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.

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

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Postoperative agitation after postoperative 30 minutes — First 30 minutes in the postoperative care unit after emergence from anesthesia.
    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.

Trial sites (1)

FacilityCityRegionStatus
Sakarya University Training and Research Hospital Sakarya Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07243990 on ClinicalTrials.gov ↗ ← All trials in Turkey