NCT03792334

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2019

Completed
Last Updated

December 9, 2020

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

December 28, 2018

Last Update Submit

December 8, 2020

Conditions

Depth of Anesthesia Monitor

Outcome Measures

Primary Outcomes (1)

  • correlation of BIS and PSI

    difference of BIS and PSI values

    through study completion, an average of 2 hours

Interventions

depth of anesthesiaDEVICE

monitoring of depth of anesthesia

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

general anesthesia

You may qualify if:

  • general anesthesia

You may not qualify if:

  • developmental delay
  • IICP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SNUH

Seoul, Jongnogu, 03080, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 35905224DERIVED

Study Officials

  • Hee-Soo Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2018

First Posted

January 3, 2019

Study Start

January 10, 2019

Primary Completion

December 26, 2019

Study Completion

December 28, 2019

Last Updated

December 9, 2020

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)