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
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|
Is it possible to use the alpha wave as an indicator of loss and recovery of consciousness in anesthesia with propofol in children?
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|
|Estimated Enrollment :||20 participants|
|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|
Electroencephalography (EEG) for induction and emergence in pediatric patients under general anesthesia with propofol.
Measure the appearance and disappearance of frontal alpha wave with EE, when them loss and recovery of consciousness under general anesthesia with 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
- 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.
- 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.
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
|Contact: VICTOR CONTRERAS, MSNfirstname.lastname@example.org|
|Contact: Win Tin Chang, MDemail@example.comfirstname.lastname@example.org|
|Santiago, Región Metropolitana, Chile, 8420525|
|Contact: VICTOR CONTRERAS, MSN 56223549217 email@example.com|
|Contact: WIN TIN CHANG, MD 56223543270 firstname.lastname@example.org|
|Sub-Investigator: Luis I Cortinez, MD|
|Principal Investigator: Win Tin Chang, MD|
|Principal Investigator:||Win Tin Chang||Pontificia Universidad Catolica de Chile|