An interventional study of dsa intervention group and Traditional Monitoring in Postoperative Agitation and Emergence Delirium, Anesthesia, sponsored by Sakarya University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Sakarya University · Not applicable, Interventional, and Diagnostic
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.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
This study's planned enrollment of 80 is below the median of 120 across 464 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Sakarya University is the lead sponsor of 190 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
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
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
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).
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.
Time frame: First 30 minutes in the postoperative care unit after emergence from anesthesia.
Ran from Sep 2026 to primary completion in Oct 2026, 1 month.
Of 184 non-industry interventional studies with no phase under Emergence Delirium, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 1 month is below that.
Counting every sponsor, half of 184 studies reached it within 19 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.