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Completed

NCT Number: NCT03195686

Efficacy of PLEM100(Inbody®) in Children

Evaluation of efficacy of PLEM100(Inbody®) in measuring the sedation level in pediatric patients

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Key information

Conditions

Development, Child

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hee-Soo Kim

Seoul, Soul-t'ukpyolsi, 03080, South Korea

About this study

The investigators plan to gather the basic data relevant to measurement of the level of consciousness/sedation in pediatric patients with developing brain by using PLEM100(Inbody®)

PLEM100 (Inbody®) is a medical equipment to measure, based on phase lag entropy algorithm, the level of patient consciousness, which is expressed by PLE score ranging from 0 (burst suppression or deep sedated) to 100 (awake).

In this study, pediatric patients aged from 3 to 6 years old who undergo total intravenous general anesthesia are chosen as target subjects. The investigators measure how PLE score changes during 1) anesthesia induction, 2) anesthesia maintenance, 3) emergence from anesthesia. Then, the PLE score would be validated by analyzing the correlation with the consciousness level expressed in University of Michigan Sedation Scale (UMSS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients to be operated under general anesthesia, aged from 3 to 6 years
  • Written Consent is available from a parent who has been explained about the study
  • Elective surgery

Exclusion criteria

  • Patients who cannot be attached by PLEM100 (Inbody®) sensors to the forehead or the side of the head
  • Patients Having Cerebral Vascular Diseases in the past or present
  • Patients with Developmental delay
  • Patients to be admitted to intensive care unit or sedated after receiving operation
  • Patients who researchers decide are not eligible to be enrolled in the study because of various factors including clinical test results.

Treatment and study plan

PLE100(Inbody®)

Device

PLE100(Inbody®) monitoring in children to be operated under the total intravenous anesthesia (Propofol)

Primary outcomes

  1. PLE100 score (0 to 100)

    Time frame: baseline and end of surgery

    Changes of PLE100 score

Secondary outcomes

  1. The level of consciousness measured in University of Michigan Sedation Scale (UMSS)

    Time frame: baseline and end of surgery

    correlation with the PLE100 scores and concentraion of propofol

  2. pharmacodynamic model

    Time frame: baseline and end of surgery

    UMSS with propofol concentration

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Efficacy of PLEM100(Inbody®) to Measure the the Sedation Level in Pediatric Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 22, 2017
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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