CClinicalTrials.gg
CompletedNCT06400706Updated Dec 29, 2025

Effect of Electroencephalography Guided General Anesthesia on Postoperative Delirium in Children

An interventional study of EEG guided general anesthesia in Postoperative Delirium and Postoperative Pain, sponsored by Aydin Adnan Menderes University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 4 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
4 Years to 10 Years
Sex
All
01

Study 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.

Read the detailed description

Postoperative delirium (POD) is an acute postoperative behavioral change defined as an impairment in the child's awareness or attention to the environment, accompanied by disorientation and perceptual changes, including hypersensitivity to stimuli and hyperactive motor behavior, usually in the immediate post-anesthesia period. The incidence of POD may depend largely on age, anesthesia technique, surgical procedure, and adjunctive medication administration. Its incidence in preschool children receiving sevoflurane anesthesia varies between 10-80%. Although POD is mostly self-limiting and occurs within the first minutes of the postoperative period, physical injuries cannot be ignored as children can move their limbs uncontrollably, get rid of their catheters, and even lose important equipment.

Prevention of POD includes pharmacological treatment and non-pharmacological treatment. Pharmacological treatment, including the administration of midazolam, ketamine, dexmedetomidine, and melatonin in the preoperative or intraoperative period, is effective, but these measures can prolong the stay in the postoperative anesthesia care unit (PACU) and cause many adverse reactions, such as postoperative nausea and vomiting, respiratory depression. Non-pharmacological treatments, such as parental companionship, preoperative education, or playing music upon entering the room, offer therapeutic effects at lower cost and greater convenience. Therefore, finding ways to prevent POD using non-pharmacological treatments is valuable.

Nowadays, more and more anesthesiologists titrate the anesthesia dose by monitoring the depth of anesthesia. In 2020, electroencephalography (EEG) monitoring was recommended by the American Society of Anesthesiologists (ASA) as one of the important organ monitoring methods to guide general anesthesia management. In the adult population, the potential benefits of monitoring intraoperative depth of anesthesia have been confirmed, including a lower incidence of hypotension under anesthesia and intraoperative awareness, faster awakening and recovery time, and reduced drug dosage use. Many meta-analyses have shown that anesthesia management through EEG monitoring can reduce the occurrence of POD in adult patients undergoing general anesthesia. EEG and depth of anesthesia monitoring have been used in pediatric anesthesia management since 2000; It is especially recommended for use in children who have undergone major or long-term surgery. EEG monitoring in pediatric anesthesia has been proven to be beneficial for children by reducing anesthetic consumption. Pediatric routine anesthesia management largely depends on the experience of the anesthesiologist.

Xu et al. reported that in pediatric surgery, EEG parameters [SEF (spectral edge frequency), PSI (patient state index), DSA (density spectral array) and raw EEG waves] may be more effective than special indices in reflecting the depth of anesthesia. Recent studies have also reported that SEF may be more effective in representing the depth of anesthesia, and that DSA can be used as a measure of the depth of anesthesia in young children undergoing sevoflurane anesthesia. In addition, in the studies of Koch et al., raw EEG features were analyzed in children undergoing general anesthesia and some relationships were found between POD and EEG epileptiform discharges. However, it is still unclear whether the use of these EEG parameters (SEF, DSA, raw EEG wave) can reduce the incidence of POD.

In this study, the investigators used SEF, PSI, DSA and EEG waves to monitor the depth of anesthesia in children. SEF, PSI, DSA and raw EEG waves can reflect the depth of anesthesia more precisely. The aim is to investigate whether the use of SEF, DSA and EEG wave measurement to guide and manage pediatric anesthesia can reduce the incidence of POD and anesthesia consumption.

02

Conditions studied

  • Postoperative Delirium
  • Postoperative Pain

Keywords

  • General anesthesia
  • Electroensephalography
  • Emergence delirium
03

In context

Emergence Delirium

763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.

This study's enrollment of 92 is below the median of 120 across 475 interventional studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    EEG Group

    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

  • No intervention
    Control

    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

  • ProcedureEEG 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.

06

What researchers measure

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.

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

Secondary outcomes

  1. Anesthetic Consumption

    Sevoflurane/Fentanyl/Rocuronium consumption during surgery

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

  2. Postoperative Pain

    FLACC scale will be used as pain scales. The highest score is 10. The more severe the child's pain, the higher the score.

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

  3. Postoperative Discomfort

    VAS-ORF scale will be used as pain scales. The highest score is 10. The more severe the child's pain, the higher the score.

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

07

Study locations

1 site
  • Aydın Adnan Menderes University
    Aydin, 09100, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 32925344 ↗
  • 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. PubMed 36138931 ↗
  • 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. PubMed 35183345 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06400706
Lead sponsor
Aydin Adnan Menderes University
Responsible party
Ozlem Kocaturk (Prof. Dr., Aydin Adnan Menderes University) — Principal investigator
First posted
May 6, 2024
Start date
May 15, 2024
Primary completion
Dec 15, 2024
Completion
May 15, 2025
Last update
Dec 29, 2025

Study contacts

Ozlem Kocaturk, MD, Prof.
study director · Adnan Menderes University Faculty Of Dentistry Division Of Anesthesiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion