Efficacy of PLEM100(Inbody®) in Children

Completed

• Conditions: Development, Child

• Registration Number: NCT03195686
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2017-06-18
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-22
• Study Start: 2017-08-15
• Primary Completion: 2018-07-29
• Study Completion: 2018-07-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-09
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PLE100 score (0 to 100)	baseline and end of surgery	Changes of PLE100 score

Secondary Outcome Measures

Name	Time	Method
pharmacodynamic model	baseline and end of surgery	UMSS with propofol concentration
The level of consciousness measured in University of Michigan Sedation Scale (UMSS)	baseline and end of surgery	correlation with the PLE100 scores and concentraion of propofol

Trial Locations

Locations (1)

Hee-Soo Kim; 🇰🇷 Seoul, Soul-t'ukpyolsi, Korea, Republic of