Predictive Model in EEG for Induction and Emergence in Pediatric With Propofol (EEGPED)

March 7, 2022 updated by: Victor Contreras, MSN

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8420525
        • Victor Contreras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Electroencephalography
Electroencephalography (EEG) for induction and emergence in pediatric patients under general anesthesia with propofol.
Device: Electroencephalography
Measure the appearance and disappearance of frontal alpha wave with EE, when them loss and recovery of consciousness under general anesthesia with propofol.
Drug: Propofol
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.
Other Names:
  • General anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Recorded by the EEG signal - 40 channels waves: Beta, Alpha,Theta
Continuously from start of propofol infusion to unarousable up to ending of infusion arouses without stimuli. In average 2 hrs.
Recovery of consciousness
Time Frame: From to ending of propofol infusion to arouses without stimuli. Continuously for 10 min.
Watching the awakening and/or gross movement. Recorded by Go Pro cam the moment of Recovery of consciousness.
From to ending of propofol infusion to arouses without stimuli. Continuously for 10 min.
Loss of consciousness
Time Frame: From start of propofol infusion to unarousable to stimuli. Continuously for 10 min.
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.
From start of propofol infusion to unarousable to stimuli. Continuously for 10 min.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial Pressure
Time Frame: 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.
By non invasive Arterial Pressure: Systolic Arterial Pressure in mmHg, diastolic Arterial Pressure in mmHg and Medium Arterial Pressure in mmHg
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.
Heart Rate
Time Frame: 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.
By EKG D-II bit per minute
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.
Saturation Oxigen
Time Frame: 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.
Pulse Oximetry by reusable sensor in % of saturation.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Victor Contreras, MSN

Collaborators

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Win Tin Chang, Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Actual)

October 15, 2021

Study Completion (Actual)

October 15, 2021

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

October 11, 2018

First Posted (Actual)

October 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180629004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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