NCT03195686

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

12 months

First QC Date

June 18, 2017

Last Update Submit

November 9, 2018

Conditions

Development, Child

Outcome Measures

Primary Outcomes (1)

  • PLE100 score (0 to 100)

    Changes of PLE100 score

    baseline and end of surgery

Secondary Outcomes (2)

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

    baseline and end of surgery

  • pharmacodynamic model

    baseline and end of surgery

Interventions

PLE100(Inbody®)DEVICE

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

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hee-Soo Kim

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

Location

Related Publications (1)

  • 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.

    PMID: 34503455DERIVED

Study Officials

  • Hee-Soo Kim, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2017

First Posted

June 22, 2017

Study Start

August 15, 2017

Primary Completion

July 29, 2018

Study Completion

July 30, 2018

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

KR(1)