Development, Child
Conditions
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).
Interventions
DEVICEPLE100(Inbody®)
PLE100(Inbody®) monitoring in children to be operated under the total intravenous anesthesia (Propofol)
Sponsors
Seoul National University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PLE100 score (0 to 100) | baseline and end of surgery | Changes of PLE100 score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| pharmacodynamic model | baseline and end of surgery | UMSS with propofol concentration |
Countries
South Korea
Outcome results
None listed