NCT03775603

Brief Summary

Comparison of TOFscan and TOF-Watch SX for monitoring of neuromuscular blockade function in children

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 2, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

December 12, 2018

Last Update Submit

April 15, 2020

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • TOF ratio of TOFscan

    value of TOF ratio of TOFscan at TOF ratio 0.7 of TOF-Watch SX during neuromuscular function recovery period

    intraoperative during anesthesia

Interventions

TOFscanDEVICE

comparison of TOFscan over TOF-Watch SX

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

general anesthesia with neuromuscular blockade in children

You may qualify if:

  • patients need neuromuscular blockade

You may not qualify if:

  • contraindication of rocuronium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • Yhim HB, Jang YE, Lee JH, Kim EH, Kim JT, Kim HS. Comparison of the TOFscan and the TOF-Watch SX during pediatric neuromuscular function recovery: a prospective observational study. Perioper Med (Lond). 2021 Dec 10;10(1):45. doi: 10.1186/s13741-021-00215-2.

    PMID: 34886885DERIVED

Study Officials

  • Hee-Soo Kim

    Seoul National University

    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 12, 2018

First Posted

December 14, 2018

Study Start

March 2, 2019

Primary Completion

January 9, 2020

Study Completion

January 30, 2020

Last Updated

April 16, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)