NCT03489785

Brief Summary

The purpose of this study was to identify the predictive factors of unpredicted movement in motor evoked potential (MEP) during intraoperative neurophysiologic monitoring in adult patients undergoing brain surgery.

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
850

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2003

Longer than P75 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

Study Start

First participant enrolled

June 1, 2003

Completed
14.8 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 30, 2018

Status Verified

January 1, 2018

Enrollment Period

15.6 years

First QC Date

March 7, 2018

Last Update Submit

April 26, 2018

Conditions

Keywords

Predicted factorMotor Evoked Potentials

Outcome Measures

Primary Outcomes (1)

  • Predictive factors of unpredicted movement

    The investigators retrospectively compare the data of patients with and without unpredictable and unacceptable movement during surgery. For continuous variables, values were compared using the independent t-test. Differences in proportions were compared using chi-square test. Variables with P-values \< 0.05 in the primary test were selected and univariate binary logistic regression analyses were conducted to identify the factors predictive of an unpredictable and unacceptable movement. P-value \< 0.05 was considered statistically significant.

    during brain surgery

Study Arms (2)

Movement

If there is unexpected movement

No movement

If there is no unexpected movement

Eligibility Criteria

Age19 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From June 2003 to August 2017, patients who underwent motor-evoked potential monitoring during brain surgery under partial neuromuscular relaxation at the Seoul National University Bundang Hospital were included in this study.

You may qualify if:

  • From June 2003 to August 2017, patients who underwent motor-evoked potential monitoring during brain surgery under partial neuromuscular relaxation at the Seoul National University Bundang Hospital.

You may not qualify if:

  • Age : 18 or younger and 75 or older
  • Anesthesiologists physical status classes III or more
  • body mass index(BMI) \< 18.5 kg/m\^2 or BMI \> 25 kg/m\^2
  • Patients who received medications that affect muscle relaxation recovery other than anticonvulsants
  • OT/PT \> 40 IU/L, Cr \> 1.4 mg/dl
  • Moderate to severe respiratory or heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Bundang-gu, South Korea

RECRUITING

MeSH Terms

Conditions

Dyskinesias

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

April 5, 2018

Study Start

June 1, 2003

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 30, 2018

Record last verified: 2018-01

Locations