Postoperative AgitationNCT07243990
Impact of Neuromonitoring on Postoperative Agitation in Pediatric General Anesthesia
A study testing dsa intervention group and Traditional Monitoring in people with Postoperative Agitation and Emergence Delirium, Anesthesia, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Postoperative Agitation, Emergence Delirium, Anesthesia
- What is being tested?
- dsa intervention group and Traditional Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2026to 1 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 6-12 years
- Without chronic comorbid conditions
- No history of epilepsy
- Presenting for surgery with preserved consciousness, oriented and cooperative
Who cannot join
- Intracranial surgeries
- Intellectual disability
- Emergency trauma cases
- Forehead area unsuitable for electrode placement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sakarya University Training and Research Hospital
Sakarya
esin topkara oğur, MD,ANESTHESIOLOGY RESIDENT, +905308583166, topkaraesin@gmail.com
About this study
Official title: 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.
- Being tested
- dsa intervention group, Traditional Monitoring
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dsa intervention groupDevice
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 MonitoringOther
This group will receive anesthesia induction using the traditional method, and monitoring will continue simultaneously with EEG (Electroencephalography).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 30 minutes in the postoperative care unit after emergence from anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start4 Sep 2026
- Primary completion20 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esin Topkara Oğur, MD, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243990
- Sponsor's protocol ID
- 2025-SEAH-ETO-DSA
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No