Impact of Neuromonitoring on Postoperative Agitation in Pediatric General Anesthesia
Postoperative Agitation · Emergence Delirium, Anesthesia
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 6 years - 12 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 80 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
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
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
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.
Traditional Monitoring OTHER
This group will receive anesthesia induction using the traditional method, and monitoring will continue simultaneously with EEG (Electroencephalography).
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Postoperative agitation after postoperative 30 minutes
Time frame: 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Sakarya University Training and Research HospitalSakarya, Turkey (Türkiye)Recruiting
Study team and timeline
- Lead sponsor
- Sakarya University
- Study start
- Sep 4, 2026 Actual
- Primary completion
- Oct 20, 2026 Actual
- Study completion
- Nov 1, 2026 Estimated
- First posted
- Nov 24, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
The Effect of Neuromonitoring on the Incidence of Postoperative Agitation in Pediatric Patients Undergoing General Anesthesia
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026