Impact of Neuromonitoring on Postoperative Agitation in Pediatric General Anesthesia

Sakarya University

Status: Not yet enrolling

Conditions: Postoperative Agitation; Emergence Delirium, Anesthesia

Treatments: Device: dsa intervention group; Other: Traditional Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07243990

2025-SEAH-ETO-DSA

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Group Monitoring-Based Care

Experimental group

Description:

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.

Treatment:

Device: dsa intervention group

Group Standart Care

Experimental group

Description:

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.

Treatment:

Other: Traditional Monitoring