Ignite Creation Date:
2024-05-06 @ 12:12 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03705338
Status:
TERMINATED
Last Update Posted:
2022-03-08
First Post:
2018-10-05
Brief Title:
Predictive Model in EEG for Induction and Emergence in Pediatric With Propofol
Sponsor:
Victor Contreras MSN
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
Elaboration of a Predictive Model in EEG for Induction and Emergence in Pediatric Patients Under General Anesthesia With Propofol
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Outbreak COVID 19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EEGPED
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None