Predictive Model in EEG for Induction and Emergence in Pediatric With Propofol

NCT03705338 | Terminated DMC FDA Drug

• 1 other identifier: 180629004
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Electroencephalography; Anesthesia; Children, Only

Keywords

Anesthesia; Children; Electroencephalography; Propofol

Outcome Measures

Primary Outcomes (3)

• Loss and Recovery of consciousness

  Recorded by the EEG signal - 40 channels waves: Beta, Alpha,Theta

  Continuously from start of propofol infusion to unarousable up to ending of infusion arouses without stimuli. In average 2 hrs.

• Recovery of consciousness

  Watching the awakening and/or gross movement. Recorded by Go Pro cam the moment of Recovery of consciousness.

  From to ending of propofol infusion to arouses without stimuli. Continuously for 10 min.

• Loss of consciousness

  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.

  From start of propofol infusion to unarousable to stimuli. Continuously for 10 min.

Secondary Outcomes (3)

• Arterial Pressure

  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

  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.

• Saturation Oxigen

  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.

Study Arms (1)

Electroencephalography

Electroencephalography (EEG) for induction and emergence in pediatric patients under general anesthesia with propofol.

Device: Electroencephalography; Drug: Propofol

Interventions

Electroencephalography DEVICE

Measure the appearance and disappearance of frontal alpha wave with EE, when them loss and recovery of consciousness under general anesthesia with propofol.

Electroencephalography

Propofol DRUG

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.

Also known as: General anesthetic

Electroencephalography

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with indications of surgery under general anesthesia and regional analgesia.

You may qualify if:

• ASA I - II
• Indications of phimosis surgery, cryptorchid and/or inguinal hernia surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Victor Contreras, MSN: lead
• Pontificia Universidad Catolica de Chile: collaborator

Study Sites (1)

Victor Contreras

Santiago, Santiago Metropolitan, 8420525, Chile

Location

Related Publications (7)

• 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.

  PMID: 11878656 BACKGROUND

• 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.

  PMID: 29120939 BACKGROUND

• 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.

  PMID: 23487781 BACKGROUND

• 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.

  PMID: 21513454 BACKGROUND

• 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.

  PMID: 28177176 BACKGROUND

• 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.

  PMID: 26102526 BACKGROUND

• 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.

  PMID: 26418126 BACKGROUND

MeSH Terms

Interventions

Electroencephalography; Propofol; Anesthetics, General

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Win Tin Chang

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator. Project Manager of Department of Anesthesiology

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 15, 2018
• Study Start: March 15, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

CL (1)