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AnesthesiaNCT06323616

The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics

A study testing MAC adjustment to PSI between 25 and 50 in people with Anesthesia and Emergence Delirium, run by Istanbul 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

Some changes in the patient's cognitive state are observed during the recovery period from general anesthesia. This period of behavioral dysregulation has been called emergence agitation (EA) and emergence delirium (ED). ED and EA occur in the early postoperative period (often within the first 30 minutes). Read more about this study

Who is it for?
Ages 2 to 8 years
What is being tested?
MAC adjustment to PSI between 25 and 50
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Feb 2024to 31 Mar 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 2 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 2 to 8 years old
  • Surgery time > 1 hour
  • Urology, Plastic Surgery and Pediatric Surgery patients

Who cannot join

  • Patients with neuromotor development abnormalities
  • Patients with a history of epilepsy/antiepileptic treatment
  • Patients receiving intraoperative ketamine administration
  • Patients requiring postoperative ICU admission
  • Surgeries performed under emergency conditions
  • Patients without parental consent

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Anesthesia Depth Monitoring on Emergence Agitation and Delirium in Pediatrics

Some changes in the patient's cognitive state are observed during the recovery period from general anesthesia. This period of behavioral dysregulation has been called emergence agitation (EA) and emergence delirium (ED). ED and EA occur in the early postoperative period (often within the first 30 minutes). The incidence of ED ranges from 10% to 80% in children and is described as a distressing clinical condition by 42% of pediatric anesthesiologists. Self-harm by the child increases the risk of delayed discharge and may increase the cost of medical care.

Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED in the pediatric population. Clinical findings are characterized by hallucinations, struggling, restlessness, crying, and disorientation.

Read more

In the literature, the Pediatric Anesthesia Rescue Delirium (PAED) Scale Score is used in the diagnosis of ED and EA. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child needs to make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the environment, the child is restless/angry, the child cannot be consoled. While the sensitivity of ≥10 points for the diagnosis of ED is 64% and the specificity is 86%, the sensitivity of >12 points for the diagnosis of ED is 100% and the specificity is 94.5%.

Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists (ASA) due to its potential benefits such as faster recovery time and lower drug dosage, as well as prevention of adverse effects such as the incidence of hypotension. The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics.

There are very few studies in the literature on the relationship between anesthesia depth monitoring and EA/ED in children, and further studies are needed.

Read the detailed description

During the compilation period after general anesthesia, cognitive status changes called emergence agitation and emergence delirium, clinically characterized by hallucinations, struggling, restlessness, crying, and disorientation, are observed. ED and EA often occur in the early postoperative period (especially in the first 30 minutes).

Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED/EA in the pediatric population. In our study, we aimed to determine the effect of sevoflurane anesthesia on the incidence of ED/EA under anesthesia depth monitoring.

Patients who give informed consent will be divided into 2 groups and randomized using the opaque sealed envelope method.

Children participating in the study will be evaluated with mYPAS, an anxiety assessment scale, in the preoperative period. Studies have found that children with high levels of anxiety have a higher frequency of developing maladaptive behavioral changes, pain, and ED after surgery.

On the day of surgery, patients will be taken to the operating room after premedication with 0.5 mg/kg po midazolam. Following routine noninvasive blood pressure, saturation and ECG monitoring; PEEG monitoring will be carried out with the help of pediatric sensors. Anesthesia guided by PEEG (processed electroencephalography) contributes to optimal targeting of the depth of anesthesia. The rationale for PEEG is to provide a simplified method for monitoring the depth of anesthesia through rapid interpretation of the frontal electroencephalogram (EEG). Thus, 4-channel raw EEG (L1, R1, L2 and R2 - equivalent to Fp1, F7, Fp2 and F8 according to the standard EEG monitoring system), electrode impedance, patient condition index (PSI), left and right spectral edge frequency (SEF95) and burst suppression ratio (SR) can be achieved. PSI; It is a dimensionless depth of anesthesia index that combines "weighted quantitative EEG parameters reflecting multiple dimensions of brain electrical activity." The correct depth of anesthesia is determined by the PSI value between 25 and 50.

Following inhaler induction with 8% sevoflurane, 0.5 mg/kg rocuronium and 2 mcg/kg fentanyl will be administered iv. Anesthesia maintenance of the patients will be provided with sevoflurane and 0.02-0.1mcg/kg/min remifentanil iv infusion.

To the control group; As we apply in routine anesthesia practice, sevoflurane anesthesia will be applied with Endtidal agent consumption of 0.8 MACage for MACage:1 with 2 standard deviations. During the surgery, parameters indicating the depth of anesthesia will be placed away from the anesthesiologist and closed to ensure blindness. At the end of the surgery, the data will be received via USB.

As for the working group; Sevoflurane anesthesia will be applied by adjusting the MAC so that the PSI median value remains between 25-50 (if PSI<25, MAC will be reduced by 0.1, if PSI>50, MAC will be increased by 0.1).

At the end of inhalation anesthesia, regional anesthesia (peripheral nerve/body block) will be applied to both groups for postoperative analgesia.

At the end of the operation, the PAED scores of all children 5, 15 and 30 minutes after extubation will be evaluated and recorded by PACU (post-anesthesia care unit) nurses who are blind to the study groups.

Ped-PADSS score, defined as the discharge score, will be checked at 30, 45 and 60 minutes in the compilation room. This score consists of 5 criteria which are vital signs, activity level, nausea-vomiting, presence of pain (<6 years OPS, >6 years VAS) and surgical bleeding. It is evaluated between 0 and 10 points, 9 points and above are safe for discharge from the compilation room.

In the post-hospital discharge period, the PHBQ scale will be administered to patients via an online survey on days 3, 14 and 28. This scale is a post-discharge behavior scale developed for children, consisting of six subscales (general anxiety, separation anxiety, sleep, eating, aggression, apathy) and 27 questions. Values between 27-135 points will be recorded and evaluated in terms of whether late-term behavioral changes occur.

There is little data in the literature on the relationship between anesthesia depth monitoring and ED during recovery in children, and further studies are needed. In our study, we think that the frequency of ED will be less in the study group than in the control group.

Being tested
MAC adjustment to PSI between 25 and 50
Medical subject headings
Emergence Delirium, Intraoperative Awareness, Postoperative Complications

What participants receive

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

  • MAC adjustment to PSI between 25 and 50Procedure or surgery

    According to SedLine monitoring, the depth of anesthesia will be adjusted by changing the amount of sevoflurane so that the PSI median value is between 25 and 50.

Study groups in NCT06323616
Study groupRoleWhat they receive
Control GroupNo interventionSevoflurane anesthesia will be applied with an endtidal agent consumption of 0.8 MACage, with 2 standard deviations for MACage:1 to the control group, as we apply in routine anesthesia practice. (During the surgery, the parameters showing the depth of anesthesia will be placed away from the anesthesiologist and covered to ensure blindness. At the end of the surgery, the data will be received via USB.)
Study GroupExperimentalSevoflurane anesthesia will be applied to the study group by adjusting the MAC to keep the PSI median value between 25-50 (if PSI<25, MAC will be reduced by 0.1, if PSI>50, MAC will be increased by 0.1).
Receives: Procedure: MAC adjustment to PSI between 25 and 50

What is being measured

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

  1. ED/EA incidence

    The Pediatric Anesthesia Recovery Delirium (PAED) Scale Score will be used. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child must make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the surroundings, the child is restless/irritable, and the child cannot be consoled. A score of ≥10 will be considered EA, and a score of >12 will be considered ED.

    Measured: postoperative 5th, 15th and 30th minutes

Secondary outcomes (21)
  1. mYPAS

    The mYPAS is an observational measure of children's preoperative anxiety consisting of 27 items divided into 5 categories: Activity, Vocalizations, Emotional Expressivity, State of Arousal and Use of Parent. Ratings produce 4 mYPAS scores (1 for each time point). Each score is calculated by dividing each item rating by the highest possible rating (i.e., 6 for the 'vocalizations' item and 4 for all other items), adding all of the produced values, dividing by 5, and multiplying by 100. This calculation produces a score ranging from 23.33 to 100 with higher values indicating higher anxiety.

    Measured: immediately before induction of anesthesia

  2. PSI <25 episode duration

    The duration of PSI <25 throughout the surgery will be calculated by looking at the trend table at the end of the surgery on the sedLine monitor.

    Measured: intraoperative

  3. PSI >50 episode duration

    The duration of PSI >50 throughout the surgery will be calculated by looking at the trend table at the end of the surgery on the sedLine monitor.

    Measured: intraoperative

  4. PSI <25 number of episodes

    If PSI <25 is observed within 15 minutes, it will be noted as an episode. More than one PSI <25 cases observed within the same 15 minutes will be included in the same episode and counted as a single episode.

    Measured: intraoperative

  5. PSI >50 number of episodes

    If PSI >50 is observed within 15 minutes, it will be noted as an episode. More than one PSI >50 cases observed within the same 15 minutes will be included in the same episode and counted as a single episode.

    Measured: intraoperative

  6. Suppresyon ratio

    The SR (Supration Ratio) parameter, which shows the depth of suppressed anesthesia on the SedLine monitor, will be recorded

    Measured: intraoperatively every 15 minutes

  7. SEF95R

    The right spectral edge frequency (SEF95R) value on the SedLine monitor will be recorded every 15 minutes

    Measured: intraoperatively every 15 minutes

  8. SEF95L

    The left spectral edge frequency (SEF95L) value on the SedLine monitor will be recorded every 15 minutes

    Measured: intraoperatively every 15 minutes

  9. Mean blood pressure

    non invasive blood pressure measurement

    Measured: intraoperatively every 15 minutes

  10. Heart rate

    ECG monitoring

    Measured: intraoperatively every 15 minutes

  11. SpO2

    pulse oximeter

    Measured: intraoperatively every 15 minutes

  12. Total amount of sevoflurane used

    At the end of the surgery, the number of milliliters will be recorded by looking at the trend parameters on the anesthesia device.

    Measured: at the end of surgery

  13. Total amount of remifentanil used

    At the end of the surgery, the total number of micrograms from the infusion pump will be recorded.

    Measured: at the end of surgery

  14. MAC

    The MACage value on the anesthesia device will be recorded every 15 minutes throughout the surgery.

    Measured: intraoperatively every 15 minutes

  15. Waking up time

    The time between the end of sevoflurane anesthesia and eye opening will be recorded with a stopwatch.

    Measured: at the end of surgery

  16. Pupil size

    3 points will be recorded as mydriasis, 1 point as miosis, and values between will be recorded as 2 points every 15 minutes.

    Measured: intraoperatively every 15 minutes

  17. Anesthesia duration

    The time between induction and awakening will be recorded using a stopwatch.

    Measured: perioperative

  18. Surgery duration

    The time between the start and end of surgery will be recorded with the help of a stopwatch.

    Measured: perioperative

  19. PHBQ

    In the period after discharge from the hospital, PHBQ (The Post Hospitalization Behavior Questionnaire) will be sent to patients via an online survey on days 3, 14 and 28. This questionnaire is a post-discharge behavior form developed for children consisting of six subscales (general anxiety, separation anxiety, sleep, eating, aggression, apathy) and 27 questions. Values between 27-135 points will be evaluated according to the record in terms of whether the change in the transition period has developed or not.

    Measured: postoperative 3rd, 14th and 28th day

  20. Ped-PADS

    The Ped-PADSS score, defined as the discharge score, will be checked by the recovery nurses at the 30th, 45th and 60th minutes. This score consists of 5 criteria (vital signs, activity level, nausea and vomiting, presence of pain (<6 years OPS, >6 years VAS) and surgical bleeding. It is evaluated between 0 and 10 points. A score of 9 points and above is safe for discharge from the recovery room. .

    Measured: postoperative 30th, 45th and 60th minutes

  21. Time of discharge from hospital

    It will be learned and recorded by calling 14 days after the operation.

    Measured: 14 days after operation

Timeline

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

  1. First posted21 Mar 2024
  2. Study start22 Feb 2024
  3. Primary completion27 Feb 2025
  4. Study completion31 Mar 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
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Single-Blind, Prospective, Interventional
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06323616
Sponsor's protocol ID
2023/2343
Status last verified
Jul 2024
First submitted
15 Mar 2024
Last updated
8 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Menser C, Smith H. Emergence Agitation and Delirium: Considerations for Epidemiology and Routine Monitoring in Pediatric Patients. Local Reg Anesth. 2020 Jul 27;13:73-83. doi: 10.2147/LRA.S181459. eCollection 2020.

    PubMed 32801855
  • Ricci Z, Robino C, Rufini P, Cumbo S, Cavallini S, Gobbi L, Brocchi A, Serio P, Romagnoli S. Monitoring anesthesia depth with patient state index during pediatric surgery. Paediatr Anaesth. 2023 Oct;33(10):855-861. doi: 10.1111/pan.14711. Epub 2023 Jun 19.

    PubMed 37334678
  • Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.

    PubMed 15562048

Questions about this trial

What is this clinical trial studying?

A study testing MAC adjustment to PSI between 25 and 50 in people with Anesthesia and Emergence Delirium, run by Istanbul 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 6 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 8 Apr 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?

ED/EA incidence (time frame: postoperative 5th, 15th and 30th minutes). 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 NCT06323616, which also lists 3 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 8 Apr 2025.

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