Predictive Model in EEG for Induction and Emergence in Pediatric With Propofol
NCT ID: NCT03705338
Last Updated: 2022-03-08
Study Results
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Basic Information
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TERMINATED
1 participants
OBSERVATIONAL
2021-03-15
2021-10-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Electroencephalography
Electroencephalography (EEG) for induction and emergence in pediatric patients under general anesthesia with propofol.
Electroencephalography
Measure the appearance and disappearance of frontal alpha wave with EE, when them loss and recovery of consciousness under general anesthesia with propofol.
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.
Interventions
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Electroencephalography
Measure the appearance and disappearance of frontal alpha wave with EE, when them loss and recovery of consciousness under general anesthesia with propofol.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Indications of phimosis surgery, cryptorchid and/or inguinal hernia surgery
Exclusion Criteria
* 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.
3 Years
11 Years
ALL
Yes
Sponsors
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Pontificia Universidad Catolica de Chile
OTHER
Victor Contreras, MSN
OTHER
Responsible Party
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Victor Contreras, MSN
Co-Investigator. Project Manager of Department of Anesthesiology
Principal Investigators
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Win Tin Chang
Role: PRINCIPAL_INVESTIGATOR
Pontificia Universidad Catolica de Chile
Locations
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Victor Contreras
Santiago, Santiago Metropolitan, Chile
Countries
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References
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Malviya S, Voepel-Lewis T, Tait AR, Merkel S, Tremper K, Naughton N. Depth of sedation in children undergoing computed tomography: validity and reliability of the University of Michigan Sedation Scale (UMSS). Br J Anaesth. 2002 Feb;88(2):241-5. doi: 10.1093/bja/88.2.241.
Cornelissen L, Donado C, Lee JM, Liang NE, Mills I, Tou A, Bilge A, Berde CB. Clinical signs and electroencephalographic patterns of emergence from sevoflurane anaesthesia in children: An observational study. Eur J Anaesthesiol. 2018 Jan;35(1):49-59. doi: 10.1097/EJA.0000000000000739.
Purdon PL, Pierce ET, Mukamel EA, Prerau MJ, Walsh JL, Wong KF, Salazar-Gomez AF, Harrell PG, Sampson AL, Cimenser A, Ching S, Kopell NJ, Tavares-Stoeckel C, Habeeb K, Merhar R, Brown EN. Electroencephalogram signatures of loss and recovery of consciousness from propofol. Proc Natl Acad Sci U S A. 2013 Mar 19;110(12):E1142-51. doi: 10.1073/pnas.1221180110. Epub 2013 Mar 4.
Brown EN, Purdon PL, Van Dort CJ. General anesthesia and altered states of arousal: a systems neuroscience analysis. Annu Rev Neurosci. 2011;34:601-28. doi: 10.1146/annurev-neuro-060909-153200.
Cornelissen L, Bergin AM, Lobo K, Donado C, Soul JS, Berde CB. Electroencephalographic discontinuity during sevoflurane anesthesia in infants and children. Paediatr Anaesth. 2017 Mar;27(3):251-262. doi: 10.1111/pan.13061. Epub 2017 Feb 8.
Cornelissen L, Kim SE, Purdon PL, Brown EN, Berde CB. Age-dependent electroencephalogram (EEG) patterns during sevoflurane general anesthesia in infants. Elife. 2015 Jun 23;4:e06513. doi: 10.7554/eLife.06513.
Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.
Other Identifiers
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180629004
Identifier Type: -
Identifier Source: org_study_id
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