Comparison of BIS and PIS in Children | NCT03792334

Studies
Comparison of BIS and PIS in Children

NCT03792334

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Dec 9, 2020Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Depth of Anesthesia Monitor

Interventions

depth of anesthesia

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2019Actual

Primary Completion Date

Dec 26, 2019Actual

Completion Date

Dec 28, 2019Actual

First Submitted Date

Dec 28, 2018

First Submission Date that Met QC Criteria

Jan 1, 2019

First Posted Date

Jan 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2020

Last Update Posted Date

Dec 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hee-Soo Kim, Principal Investigator, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparison of bispectral index and patient sedation index during general anesthesia in children

Detailed Description

the values of BIS and PSI of every 1 minute during general anesthesia in children

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
depth of anesthesia	Device	monitoring of depth of anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation of BIS and PSI	difference of BIS and PSI values	through study completion, an average of 2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

general anesthesia

Exclusion Criteria:

developmental delay
IICP

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

general anesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hee-Soo Kim, MD, PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SNUH		Seoul	Jongnogu	03080	South Korea
Seoul National University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35905224	Derived	Jang YE, Kim EH, Lee JH, Kim JT, Kim HS. Usefulness of bispectral index and patient state index during sevoflurane anesthesia in children: A prospective observational study. Medicine (Baltimore). 2022 Jul 29;101(30):e29925. doi: 10.1097/MD.0000000000029925.