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Postoperative DeliriumNCT06400706

Effect of Electroencephalography Guided General Anesthesia on Postoperative Delirium in Children

A study testing EEG guided general anesthesia in people with Postoperative Delirium and Postoperative Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Delirium, Postoperative Pain
What is being tested?
EEG guided general anesthesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2024to 15 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Aydın Adnan Menderes University

    Aydin, 09100

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Electroencephalography (SEF and PSI) Guided General Anesthesia on Postoperative Delirium and Anesthetic Consumption in Children Underwent Dental Rehabilitation: A Randomized Controlled Trial

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.

Read more

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.

Being tested
EEG guided general anesthesia
Keywords
General anesthesia, Electroensephalography, Emergence delirium
Medical subject headings
Emergence Delirium, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EEG guided general anesthesiaProcedure or surgery

    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.

Study groups in NCT06400706
Study groupRoleWhat they receive
EEG GroupExperimentalEEG 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.
Receives: Procedure: EEG guided general anesthesia
ControlNo interventionStandard 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)
  1. Anesthetic Consumption

    Sevoflurane/Fentanyl/Rocuronium consumption during surgery

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2024
  2. Study start15 May 2024
  3. Primary completion15 Dec 2024
  4. Study completion15 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06400706
Sponsor's protocol ID
AADUDHF 2023/34
Status last verified
Dec 2025
First submitted
21 Apr 2024
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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
  • Kocaturk O, Keles S. EEG-Guided Sevoflurane Anesthesia and Emergence Delirium in Children: A Randomized Controlled Trial. Paediatr Anaesth. 2026 Aug 12. doi: 10.1002/pan.70279. Online ahead of print.

    PubMed 42590887

Questions about this trial

What is this clinical trial studying?

A study testing EEG guided general anesthesia in people with Postoperative Delirium and Postoperative Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Emergence Delirium (time frame: From date of randomization until the date of first documented progression (up to thirty weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06400706, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.

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