Effect of Electroencephalography Guided General Anesthesia on Postoperative Delirium in Children
NCT06400706 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92
Last updated 2025-12-29
Summary
Participants aged 4-10 years (92 patients), who came to the Hospital Operating Room at the University Faculty of Dentistry with an indication for dental treatment under general anesthesia due to lack of cooperation, will be selected by simple randomization and divided into 2 groups. One group of participants who will undergo routine general anesthesia and dental treatment procedures will receive routine monitoring (Group I), and the other group will receive EEG monitoring (Group II) in addition to routine monitoring. Electrocardiography (ECG), oxygen saturation (SpO2), non-invasive blood pressure (NIBP), endtidal carbon dioxide (EtCO2), endtidal sevoflurane (EtSev) parameters observed as routine monitoring of the patients will be recorded and the minimal alveolar concentration (MAC) value will be kept at 0.9. Anesthesia management will be performed, and in Group II, in addition to routine monitoring, anesthesia management will be carried out to keep the SEF values observed in the EEG between 10-15 and PSI values between 25-50. Routine general anesthesia procedures and dental treatments will not differ between groups.
Age, gender, weight, intubation type, ASA, previous surgical experience, anesthesia duration, number of extracted teeth with decayed fillings (dmft) values will also be recorded.
In the intraoperative period; hemodynamic parameters (average heart rate, blood pressure and oxygen saturation values) and amounts of medication consumed (most tidal sevoflurane percentages in induction and maintenance, presence of burst suppression, sevoflurane/fentanyl/rocuronium consumption). The participants, whose operation is completed, will be taken to the recovery room and any post-operative discomfort will be noted. The cases will be recorded in the report form.
In the postoperative period; Extubation time, agitation (PAED scores) and pain (FLACC, VAS-ORF) scores will be recorded during extubation and 10, 20, 30 minutes and 2 hours after extubation, and recovery time, hospital stay, presence of nausea and vomiting will also be recorded.
Modified Aldrete Recovery Score (MAS) will be used for recovery criteria and MAS \>8 will be considered as a recovery indicator. The Pediatric Anesthesia Early Delirium Scale (PAED) will be used to evaluate early agitation. FLACC and VAS-ORF scale will be used as pain scales.
Conditions
- Postoperative Delirium
- Postoperative Pain
Interventions
- PROCEDURE
-
EEG guided general anesthesia
EEG guided general anesthesia: General anesthesia is guided by SedLine (EEG-guided care). The goal of EEG-guided care is to maintain spectral edge frequency (SEF) between 10 and 15 and patient state index (PSI) between 25 and 50.
Sponsors & Collaborators
-
Aydin Adnan Menderes University
lead OTHER
Principal Investigators
-
Ozlem Kocaturk, MD, Prof. · Adnan Menderes University Faculty Of Dentistry Division Of Anesthesiology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 4 Years
- Max Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-05-15
- Primary Completion
- 2024-12-15
- Completion
- 2025-05-15
Countries
- Turkey (Türkiye)
Study Locations
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