Clinical trial NCT03705338: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Electroencephalography
Anesthesia
Children, Only
Keywords: Anesthesia
Children
Electroencephalography
Propofol
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Catolica de Chile
First posted: 2018-10-15
Enrollment: 1
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with indications of surgery under general anesthesia and regional analgesia.

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.

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.

Primary outcomes:
measure: Loss and Recovery of consciousness
timeFrame: Continuously from start of propofol infusion to unarousable up to ending of infusion arouses without stimuli. In average 2 hrs.
measure: Recovery of consciousness
timeFrame: From to ending of propofol infusion to arouses without stimuli. Continuously for 10 min.
measure: Loss of consciousness
timeFrame: From start of propofol infusion to unarousable to stimuli. Continuously for 10 min.
Secondary outcomes:
measure: Arterial Pressure
timeFrame: 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.
measure: Heart Rate
timeFrame: 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.
measure: Saturation Oxigen
timeFrame: 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.
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Victor Contreras
state: Región Metropolitana
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Win Tin Chang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.