Development, Child Clinical Trial
Official title:
Efficacy of PLEM100(Inbody®) to Measure the the Sedation Level in Pediatric Patients
NCT number | NCT03195686 |
Other study ID # | 1795-110-855 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 15, 2017 |
Est. completion date | July 30, 2018 |
Verified date | November 2018 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Evaluation of efficacy of PLEM100(Inbody®) in measuring the sedation level in pediatric patients
Status | Completed |
Enrollment | 60 |
Est. completion date | July 30, 2018 |
Est. primary completion date | July 29, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 6 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hee-Soo Kim | Seoul | Soul-t'ukpyolsi |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PLE100 score (0 to 100) | Changes of PLE100 score | baseline and end of surgery | |
Secondary | The level of consciousness measured in University of Michigan Sedation Scale (UMSS) | correlation with the PLE100 scores and concentraion of propofol | baseline and end of surgery | |
Secondary | pharmacodynamic model | UMSS with propofol concentration | baseline and end of surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
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