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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07243990
Enrollment
80
Registered
2025-11-24
Start date
2026-09-04
Completion date
2026-11-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium, Anesthesia, Postoperative Agitation

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.

Interventions

DEVICEdsa 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.

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

Sponsors

Sakarya University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative agitation after postoperative 30 minutesFirst 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTesin topkara oğur, MD,ANESTHESIOLOGY RESIDENT
topkaraesin@gmail.com+905308583166

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026