Sakarya University Training and Research Hospital
Sakarya, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07243990
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.
Interested in participating?
Request Info6 year–12 year
All sexes
Interventional
Not applicable
Sakarya, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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).
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.
Interested in participating?
Request InfoSakarya University
Other
The Effect of Neuromonitoring on the Incidence of Postoperative Agitation in Pediatric Patients Undergoing General Anesthesia
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