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

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ClinicalTrials.gov Identifier: NCT03705338
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Victor Contreras, MSN, Pontificia Universidad Catolica de Chile

Brief 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.

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.


Condition or disease Intervention/treatment
Electroencephalography Anesthesia Children, Only Device: Electroencephalography Drug: Propofol

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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Elaboration of a Predictive Model in EEG for Induction and Emergence in Pediatric Patients Under General Anesthesia With Propofol
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

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 Name: General anesthetic




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.



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Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children with indications of surgery under general anesthesia and regional analgesia.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705338


Contacts
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Contact: VICTOR CONTRERAS, MSN 56223549217 vecontre@uc.cl
Contact: Win Tin Chang, MD wintinchang@gmail.com wintinchang@gmail.com

Locations
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Chile
Victor Contreras Recruiting
Santiago, Región Metropolitana, Chile, 8420525
Contact: VICTOR CONTRERAS, MSN    56223549217    vecontre@uc.cl   
Contact: WIN TIN CHANG, MD    56223543270    wintinchang@gmail.com   
Sub-Investigator: Luis I Cortinez, MD         
Principal Investigator: Win Tin Chang, MD         
Sponsors and Collaborators
Victor Contreras, MSN
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Win Tin Chang Pontificia Universidad Catolica de Chile

Publications:

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Responsible Party: Victor Contreras, MSN, Co-Investigator. Project Manager of Department of Anesthesiology, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03705338     History of Changes
Other Study ID Numbers: 180629004
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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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

Keywords provided by Victor Contreras, MSN, Pontificia Universidad Catolica de Chile:
Anesthesia
Children
Electroencephalography
Propofol

Additional relevant MeSH terms:
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Anesthetics
Propofol
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous