AzTrials
AzTrials

ElectroencephalographyEEGPEDNCT03705338

Predictive Model in EEG for Induction and Emergence in Pediatric With Propofol

An observational study of Electroencephalography and Anesthesia, run by Victor Contreras, MSN at 1 site in Chile.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Anesthesia is essential to control pain and produce unconsciousness during surgery and other procedures during childhood. The anesthetic deepness is measured indirectly through changes in blood pressure and heart rate or can be inferred according to estimated or measured concentrations of anesthetics. Read more about this study

Who is it for?
Ages 3 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Electroencephalography, Anesthesia, Children, Only
What is being tested?
Electroencephalography and Propofol
How many people
1 participants
Where
1 siteChile
Study dates
15 Mar 2021to 15 Oct 2021
Phase
Observational
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 3 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children with indications of surgery under general anesthesia and regional analgesia.

Who may be able to join

  • ASA I - II
  • Indications of phimosis surgery, cryptorchid and/or inguinal hernia surgery

Who cannot join

  • Anatomical limitations for installing the EEG cap.
  • Congenital or genetic malformations that influence his/her brain development.
  • Neurological or cardiovascular disease
  • Use of drugs with effect in the CNS in the last 24 hrs.
  • Preterm newborn less than 32 weeks.

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Victor Contreras

    Santiago, Santiago Metropolitan, 8420525

Other trials in Chile

About this study

Official title: Elaboration of a Predictive Model in EEG for Induction and Emergence in Pediatric Patients Under General Anesthesia With Propofol

Anesthesia is essential to control pain and produce unconsciousness during surgery and other procedures during childhood. The anesthetic deepness is measured indirectly through changes in blood pressure and heart rate or can be inferred according to estimated or measured concentrations of anesthetics.

In adults, anesthetic dosing, using patterns based on electroencephalogram (EEG) analysis, has shown clinical advantages compared to traditional monitoring. These advantages include lower consumption of hypnotics, less post-operative cognitive deterioration and decreased intraoperative awakening.

Read more

The maturation of the brain and Central Nervous System (CNS) that occurs in childhood affects the response of anesthetics. Additionally, the EEG changes with age and its dominant frequency is lower in children. This explains why brain monitoring methods developed in adults do not work well in children. However, these patterns cannot be extrapolated to the pediatric population. Therefore, it is necessary to develop indexes based on EEG with pediatric data to improve the dosage of hypnotics in this population.

The appearance of alpha wave in frontal EEG has been successfully used as a marker of unconsciousness during general anesthesia with GABAergic hypnotics in adults (sevoflurane, propofol). However, in children, the alpha wave appears since 4 months of age in anesthetics with sevoflurane, so studying the characterization of this wave during the loss and recovery of secondary consciousness anesthetic agents such as propofol has not been studied yet.

Read the detailed description

Research question:

Is it possible to use the alpha wave as an indicator of loss and recovery of consciousness in anesthesia with propofol in children?

Hypothesis:

The appearance and disappearance of frontal alpha wave is a good indicator of loss and recovery of consciousness in anesthesia with propofol in children.

Being tested
Electroencephalography, Propofol
Keywords
Anesthesia, Children, Electroencephalography, Propofol

What participants receive

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

  • ElectroencephalographyDevice

    Measure the appearance and disappearance of frontal alpha wave with EE, when them loss and recovery of consciousness under general anesthesia with propofol.

  • PropofolDrug

    Also called General anesthetic

    Recorder the loss and recovery of consciousness in children under general anesthesia with TCI of propofol intravenous. Induction will be started with 20 mg/kg/hr of propofol up to UMSS level 4. Then will be titrated leading anesthesiologist criteria.

Study groups in NCT03705338
Study groupRoleWhat they receive
ElectroencephalographyElectroencephalography (EEG) for induction and emergence in pediatric patients under general anesthesia with propofol.
Receives: Device: Electroencephalography; Drug: Propofol

What is being measured

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

  1. Loss and Recovery of consciousness

    Recorded by the EEG signal - 40 channels waves: Beta, Alpha,Theta

    Measured: Continuously from start of propofol infusion to unarousable up to ending of infusion arouses without stimuli. In average 2 hrs.

  2. Recovery of consciousness

    Watching the awakening and/or gross movement. Recorded by Go Pro cam the moment of Recovery of consciousness.

    Measured: From to ending of propofol infusion to arouses without stimuli. Continuously for 10 min.

  3. Loss of consciousness

    Level 4 of University of Michigan Sedation Scale for children [0 0=awake/alert; 1=sleepy/responds appropriately; 2=somnolent/arouses to light stimuli ; 3=deep sleep/arouses to deeper physical stimuli; 4=unarousable to stimuli]. Recorded by Go Pro cam the moment of loss consciousness.

    Measured: From start of propofol infusion to unarousable to stimuli. Continuously for 10 min.

Secondary outcomes (3)

  1. Arterial Pressure

    By non invasive Arterial Pressure: Systolic Arterial Pressure in mmHg, diastolic Arterial Pressure in mmHg and Medium Arterial Pressure in mmHg

    Measured: Entering operating room every 1 min per 5 min and every 5 min up to end of anesthesia or recovery of consciousness. In average 2 hrs.

  2. Heart Rate

    By EKG D-II bit per minute

    Measured: Entering operating room every 1 min per 5 min and every 5 min up to end of anesthesia or recovery of consciousness. In average 2 hrs.

  3. Saturation Oxigen

    Pulse Oximetry by reusable sensor in % of saturation.

    Measured: Entering operating room every 1 min per 5 min and every 5 min up to end of anesthesia or recovery of consciousness. In average 2 hrs.

Timeline

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

  1. First posted15 Oct 2018
  2. Study start15 Mar 2021
  3. Primary completion15 Oct 2021
  4. Study completion15 Oct 2021

Why it stopped: Outbreak COVID 19

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03705338
Sponsor's protocol ID
180629004
Acronym
EEGPED
Status last verified
Mar 2022
First submitted
5 Oct 2018
Last updated
8 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Malviya S, Voepel-Lewis T, Tait AR, Merkel S, Tremper K, Naughton N. Depth of sedation in children undergoing computed tomography: validity and reliability of the University of Michigan Sedation Scale (UMSS). Br J Anaesth. 2002 Feb;88(2):241-5. doi: 10.1093/bja/88.2.241.

    PubMed 11878656

  • Cornelissen L, Donado C, Lee JM, Liang NE, Mills I, Tou A, Bilge A, Berde CB. Clinical signs and electroencephalographic patterns of emergence from sevoflurane anaesthesia in children: An observational study. Eur J Anaesthesiol. 2018 Jan;35(1):49-59. doi: 10.1097/EJA.0000000000000739.

    PubMed 29120939

  • Purdon PL, Pierce ET, Mukamel EA, Prerau MJ, Walsh JL, Wong KF, Salazar-Gomez AF, Harrell PG, Sampson AL, Cimenser A, Ching S, Kopell NJ, Tavares-Stoeckel C, Habeeb K, Merhar R, Brown EN. Electroencephalogram signatures of loss and recovery of consciousness from propofol. Proc Natl Acad Sci U S A. 2013 Mar 19;110(12):E1142-51. doi: 10.1073/pnas.1221180110. Epub 2013 Mar 4.

    PubMed 23487781

  • Brown EN, Purdon PL, Van Dort CJ. General anesthesia and altered states of arousal: a systems neuroscience analysis. Annu Rev Neurosci. 2011;34:601-28. doi: 10.1146/annurev-neuro-060909-153200.

    PubMed 21513454

  • Cornelissen L, Bergin AM, Lobo K, Donado C, Soul JS, Berde CB. Electroencephalographic discontinuity during sevoflurane anesthesia in infants and children. Paediatr Anaesth. 2017 Mar;27(3):251-262. doi: 10.1111/pan.13061. Epub 2017 Feb 8.

    PubMed 28177176

  • Cornelissen L, Kim SE, Purdon PL, Brown EN, Berde CB. Age-dependent electroencephalogram (EEG) patterns during sevoflurane general anesthesia in infants. Elife. 2015 Jun 23;4:e06513. doi: 10.7554/eLife.06513.

    PubMed 26102526

  • Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.

    PubMed 26418126

Questions about this trial

What is this clinical trial studying?

An observational study of Electroencephalography and Anesthesia, run by Victor Contreras, MSN at 1 site in Chile.

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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Mar 2022. 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 Chile. 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 was stopped early (reason given: Outbreak COVID 19). Results are not available in the source record.

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?

Loss and Recovery of consciousness (time frame: Continuously from start of propofol infusion to unarousable up to ending of infusion arouses without stimuli. In average 2 hrs.). The study lists 3 primary outcomes in all. 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 NCT03705338, which also lists 7 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 Mar 2022.

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