Efficacy of PLEM100(Inbody®) in Children

N/ACompletedNCT03195686

Seoul National University Hospital60 enrolled

Overview

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

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Development, Child

Interventions

PLE100(Inbody®)DEVICE

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

Eligibility

Sex: ALLMin age: 3 YearsMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hee-Soo Kim

Seoul, Soul-t'ukpyolsi, South Korea

Outcomes

Primary Outcomes

PLE100 score (0 to 100)

Changes of PLE100 score

Time frame: baseline and end of surgery

Secondary Outcomes

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

pharmacodynamic model

UMSS with propofol concentration

Time frame: baseline and end of surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.