Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 770 for:    region | Chile

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date October 5, 2018
First Posted Date October 15, 2018
Last Update Posted Date May 1, 2019
Actual Study Start Date March 15, 2019
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 11, 2018)
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03705338 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 15, 2018)
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures
 (submitted: October 11, 2018)
  • Hemodinamic [ 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. ]
    Arterial Pressure systolic (mmHg) and Arterial Pressure diastolic (mmHg)
  • Hemodinamic [ 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. ]
    Heart Rate (bpm)
  • Oximetry [ 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. ]
    plethysmography of pulse oximeter
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictive Model in EEG for Induction and Emergence in Pediatric With Propofol
Official Title Elaboration of a Predictive Model in EEG for Induction and Emergence in Pediatric Patients Under General Anesthesia With Propofol
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.

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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children with indications of surgery under general anesthesia and regional analgesia.
Condition
  • Electroencephalography
  • Anesthesia
  • Children, Only
Intervention
  • 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
Study Groups/Cohorts Electroencephalography
Electroencephalography (EEG) for induction and emergence in pediatric patients under general anesthesia with propofol.
Interventions:
  • Device: Electroencephalography
  • Drug: Propofol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 11, 2018)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 15, 2020
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 11 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: VICTOR CONTRERAS, MSN 56223549217 vecontre@uc.cl
Contact: Win Tin Chang, MD wintinchang@gmail.com wintinchang@gmail.com
Listed Location Countries Chile
Removed Location Countries  
 
Administrative Information
NCT Number NCT03705338
Other Study ID Numbers 180629004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Victor Contreras, MSN, Pontificia Universidad Catolica de Chile
Study Sponsor Victor Contreras, MSN
Collaborators Pontificia Universidad Catolica de Chile
Investigators
Principal Investigator: Win Tin Chang Pontificia Universidad Catolica de Chile
PRS Account Pontificia Universidad Catolica de Chile
Verification Date April 2019