Predictive Factors of Unpredicted Movement in Motor Evoked Potential

April 26, 2018 updated by: Seoul National University Hospital

Predictive Factors of Unpredicted Movement in Motor Evoked Potential During Intraoperative Neurophysiologic Monitoring in Adult Patients Undergoing Brain Surgery.

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

Despite advances in neuroendovascular techniques, several complications can occur by brain urgery. Therefore, for neurosurgeons and anesthesiologists, it is a major concern to describe and monitor surgical lesion for maintaining structural and functional integrity as well as achieving maximal cytoreduction in lesion, and modifying the management of patients on the process of surgery. For example, microvascular Doppler sonography, indocyanine green aniography, intraoperative digital subtraction angiography, and intraoperative neurophysiologic monitoring (IONM) are used for this purpose.

The incidence of unpredictable and unacceptable movement is relative low. However, the results are so horrendous that they can cause injuries in site of rigid pin fixation of the head, cervical spine injuries, excessive surgical field movement, and deterioration of surgical outcome. However, risk factors associated with unpredictable and unacceptable movement remain unclear. Therefore, the aim of this retrospective study was to evaluate risk factors associated with unpredictable and unacceptable movement in the patients who underwent brain surgery with MEP monitoring under general anesthesia while using neuromuscular blocking agent.

The investigators recorded demographic data including age in years, sex, height in meters, weight in kilograms, body mass index (BMI in kg/m^2), ASA physical status class, diagnosed disease, performed surgical procedure, duration of anesthesia in minutes, duration of surgery in minutes, underlying disease (e.g. hypertension, diabetes, neurologic disease, respiratory disease), medications. Laboratory data was also collected including arterial blood gas analysis, hematocrit, hemoglobin, sodium, potassium, ionized calcium, ionized magnesium, and lactate. Unpredictable and unacceptable movement was defined as either the dangerous gross movement requiring the increase the continuous infusion rate of rocuronium in view of the surgeon, anesthesiologist, and neurophysiologic specialist or the shake of the surgical field requiring the increase the continuous infusion rate of rocuronium.

Study Type

Observational

Enrollment (Anticipated)

850

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Bundang-gu
      • Seongnam-si, Bundang-gu, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Movement
If there is unexpected movement
No movement
If there is no unexpected movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive factors of unpredicted movement
Time Frame: during brain surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2003

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 29, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1801-444-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe