Effect of Electroencephalography Guided General Anesthesia on Postoperative Delirium in Children

NCT06400706 | Completed

• 1 other identifier: AADUDHF 2023/34
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

General anesthesia; Electroensephalography; Emergence delirium

Outcome Measures

Primary Outcomes (1)

• Postoperative Emergence Delirium

  It is measured with the Pediatric Anesthesia Emergency Delirium Scale (PAEDS). The higher the score, the more severe the child's agitation; Scores \> 2 indicate postoperative agitation, scores \> 10 indicate postoperative delirium.

  From date of randomization until the date of first documented progression (up to thirty weeks)

Secondary Outcomes (3)

• Anesthetic Consumption

  From date of randomization until the date of first documented progression (up to thirty weeks)

• Postoperative Pain

  From date of randomization until the date of first documented progression (up to thirty weeks)

• Postoperative Discomfort

  From date of randomization until the date of first documented progression (up to thirty weeks

Study Arms (2)

EEG Group

EXPERIMENTAL

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.

Procedure: EEG guided general anesthesia

Control

NO INTERVENTION

Standard general anesthesia: Anesthesia management is performed to keep the minimal alveolar concentration (MAC) value at 0.9 and intraoperative drug use is adjusted according to the experience of the anesthesiologist.

Interventions

EEG guided general anesthesia PROCEDURE

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.

EEG Group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA I and II,
• Those who will undergo elective dental procedures under general anesthesia
• Cases where anesthesia duration will be more than 1 hour

You may not qualify if:

• Having a history of serious neurological or mental illness
• Having growth-developmental retardation
• Parents or children do not want to participate in the study or are participating in another research study at the same time.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (3)

• Tang CJ, Jin Z, Sands LP, Pleasants D, Tabatabai S, Hong Y, Leung JM. ADAPT-2: A Randomized Clinical Trial to Reduce Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery. Anesth Analg. 2020 Oct;131(4):1228-1236. doi: 10.1213/ANE.0000000000004713.

  PMID: 32925344 BACKGROUND

• Han Y, Miao M, Li P, Yang Y, Zhang H, Zhang B, Sun M, Zhang J. EEG-Parameter-Guided Anesthesia for Prevention of Emergence Delirium in Children. Brain Sci. 2022 Sep 5;12(9):1195. doi: 10.3390/brainsci12091195.

  PMID: 36138931 RESULT

• Sumner M, Deng C, Evered L, Frampton C, Leslie K, Short T, Campbell D. Processed electroencephalography-guided general anaesthesia to reduce postoperative delirium: a systematic review and meta-analysis. Br J Anaesth. 2023 Feb;130(2):e243-e253. doi: 10.1016/j.bja.2022.01.006. Epub 2022 Feb 17.

  PMID: 35183345 RESULT

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain

Study Officials

• Ozlem Kocaturk, MD, Prof.

  Adnan Menderes University Faculty Of Dentistry Division Of Anesthesiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: May 6, 2024
• Study Start: May 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: May 15, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)