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CompletedNCT03195686Updated Nov 14, 2018

Efficacy of PLEM100(Inbody®) in Children

An observational study in Development, Child, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2018-11-14.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
3 Years to 6 Years
Sex
All
01

Study summary

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

Read the detailed description

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).

02

Conditions studied

  • Development, Child
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric patients to be operated under general anesthesia, aged from 3 to 6 years

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Interventions

  • DevicePLE100(Inbody®)

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

06

What researchers measure

Primary outcomes

  1. PLE100 score (0 to 100)

    Changes of PLE100 score

    Time frame: baseline and end of surgery

Secondary outcomes

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

    correlation with the PLE100 scores and concentraion of propofol

    Time frame: baseline and end of surgery

  2. pharmacodynamic model

    UMSS with propofol concentration

    Time frame: baseline and end of surgery

07

Study locations

1 site
  • Hee-Soo Kim
    Seoul, Soul-t'ukpyolsi 03080, Korea, Republic of
08

References and documents

Publications

  • Jang YE, Ji SH, Lee JH, Kim EH, Kim JT, Kim HS. The relationship between the effect-site concentration of propofol and sedation scale in children: a pharmacodynamic modeling study. BMC Anesthesiol. 2021 Sep 9;21(1):222. doi: 10.1186/s12871-021-01446-y. PubMed 34503455 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03195686
Lead sponsor
Seoul National University Hospital
Responsible party
Hee-Soo Kim (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jun 22, 2017
Start date
Aug 15, 2017
Primary completion
Jul 29, 2018
Completion
Jul 30, 2018
Last update
Nov 14, 2018

Study contacts

Hee-Soo Kim, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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