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Impact of Neuromonitoring on Postoperative Agitation in Pediatric General Anesthesia

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Mar 1, 2026 → Oct 20, 2026
See other at-risk trials from Sakarya University

Record History

  1. Notable Primary completion pushed from Mar 1, 2026 to Oct 20, 2026
    • Recruitment opened
    • Start date changed from estimate of Dec 30, 2025 to Sep 4, 2026
    • Study completion pushed from Jun 1, 2026 to Nov 1, 2026
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07243990
Lead Sponsor Sakarya University
Conditions
(from sponsor)
Postoperative Agitation, Emergence Delirium, Anesthesia
Related terms Emergence Delirium
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov