Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years

NCT02481999 | Terminated

• 1 other identifier: Narco-Kids
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of mechanisms and factors of anaesthesia on postoperative delirium and emergence agitation as well as on postoperative cognitive function in children aged 0,5-8 years scheduled for elective surgery. The depth of anesthesia in children for elective surgery aged 0,5-6 years is monitored with intraoperative "Narcotrend-Compact-M-Monitoring". Postoperatively the "Pediatric Anesthesia Emergence Delirium Scores (PAED Score)" \[Sikich et al. 2004;Locatelli et al. 2013\] is used to screen for the frequency of postoperative delirium in the post anesthesia care unit discharge of the child after surgery. Cognitive testings are performed in children of the study group (n= 470) and a control group (n= 80) with the parents support to evaluate deficits in children in their cognitive areas (POCD (Postoperative cognitive deficit)) at three different time points up to three months.

Conditions

Anesthesia

Keywords

Depth of anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of emergence delirium and postoperative delirium

  The Delirium is measured by the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004; Locatelli et al. 2013)

  Until discharge of the child from the recovery room, an expected average of 1 hour

Secondary Outcomes (45)

• Depth of anesthesia

  During the operation

• Incidence of behavioral problem

  Up to 5 postoperative days

• Severity of emergence Delirium

  Until discharge of the child from the recovery room, an expected average of 1 hour

• Duration of emergence Delirium

  Until discharge of the child from the recovery room, an expected average of 1 hour

• Lactate

  Up to 5 postoperative days

Other Outcomes (7)

• Age

  At the beginning of the investigation

• ASA classification

  At the beginning of the investigation

• Medical history

  At the beginning of the investigation

Study Arms (2)

Study group: Patients

470 children for elective surgery 0,5 to 8 years Analysis of EEG data will divided in four age-related groups because of the different baseline EEG activity: * 0.5 - 12 month: 5-7 Hz activity / blocked by eye opening * 12 - 36 month: 7-8 Hz activity / Variability 5 - 10 Hz * 3 - 6 years: 8 Hz activity / amplitude 100µV * 6 - 8 years 10Hz activity / amplitude 100 µV

Control group: Healthy children for POCD assessment

80 healthy children (siblings of study group children and children from Kindergarten) 0,5 to 8 years with no operation

Eligibility Criteria

• Age: 6 Months - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children for elective surgery aged from 0, 5 to 8 years

You may qualify if:

• male or female children 0,5 to 8 years
• planned elective surgery
• informed consent by both parents, if both parents have joint custody

You may not qualify if:

• indication for isolation of patients with multi-resistant bacteria
• known neurological or psychiatric precondition (disease)
• inability of the parents to speak and or read German
• lacking willingness to save and hand out pseudonomized data within the clinical study
• contact allergy to silver or silver chloride
• participation in another prospective interventional clinical study during this study
• Control Group:
• male or female healthy children 0,5 to 8 years (siblings of study group and children from kindergarten)
• no planned operation in the next three month
• informed consent by both parents, if both parents have joint custody
• Neurological or psychiatric precondition (disease), which limits the conduction of the neurocognitive testing
• Anacusis or Hypoacusis, which limits the conduction of the neurocognitive testing
• Taking psychotropic drugs (including sleep-inducing drug and benzodiazepine) on a regular basis and substances, which limit the conduction of the neurocognitive testing
• Inability of the parents to speak and or read the used language
• Lacking willingness to save and hand out pseudonomized data within the clinical study

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - University Medicine Berlin

Berlin, 13353, Germany

Location

Related Publications (3)

• Koch S, Stegherr AM, Rupp L, Kruppa J, Prager C, Kramer S, Fahlenkamp A, Spies C. Emergence delirium in children is not related to intraoperative burst suppression - prospective, observational electrography study. BMC Anesthesiol. 2019 Aug 8;19(1):146. doi: 10.1186/s12871-019-0819-2.

  PMID: 31395011 DERIVED

• Koch S, Rupp L, Prager C, Wernecke KD, Kramer S, Fahlenkamp A, Spies CD. Emergence delirium in children is related to epileptiform discharges during anaesthesia induction: An observational study. Eur J Anaesthesiol. 2018 Dec;35(12):929-936. doi: 10.1097/EJA.0000000000000867.

  PMID: 30113351 DERIVED

• Koch S, Rupp L, Prager C, Morgeli R, Kramer S, Wernecke KD, Fahlenkamp A, Spies C. Incidence of epileptiform discharges in children during induction of anaesthesia using Propofol versus Sevoflurane. Clin Neurophysiol. 2018 Aug;129(8):1642-1648. doi: 10.1016/j.clinph.2018.05.013. Epub 2018 Jun 8.

  PMID: 29913339 DERIVED

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK)

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 25, 2015
• Study Start: September 8, 2015
• Primary Completion: February 22, 2017
• Study Completion: May 24, 2017
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

DE (1)