NCT05963256

Brief Summary

This study was aimed to investigate a prediction model for predicting train-of-four (TOF) 50% in patients undergoing neurosurgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 19, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

Same day

First QC Date

July 19, 2023

Last Update Submit

July 27, 2023

Conditions

Neurophysiologic Monitoring

Outcome Measures

Primary Outcomes (1)

  • Train-of-four (TOF) ratio

    The ratio of the height of the fourth muscle response to the first one following the nerve stimulation

    30 minutes after reaching the TOF plateau

Interventions

Twitch Electrode ArrayDEVICE

Monitor train-of-four (TOF) count and percentage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient undergoing neurosurgery

You may qualify if:

  • patient undergoing neurosurgery
  • scheduled for intra-operative neurophysiological monitoring
  • American Society of Anesthesiologists physical class I, II, III

You may not qualify if:

  • unable to monitor train-of-four
  • decline to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eunah Cho

Seoul, 03181, South Korea

RECRUITING

Study Officials

  • Eunah Cho, PhD

    KangbukSamsung Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunah Cho, PhD

CONTACT

82-10-9480-0531mintflavored@naver.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 27, 2023

Study Start

July 20, 2023

Primary Completion

July 20, 2023

Study Completion

July 20, 2024

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations

KR(1)