Predictive Factors of Unpredicted Movement in Motor Evoked Potential

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03489785

Collaborator

(none)

850

Enrollment

Location

187

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Involuntary Movements Brain Surgery

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 Design

Study Type:

Observational

Anticipated Enrollment :

850 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2003

Anticipated Primary Completion Date :

Dec 31, 2018

Anticipated Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Movement If there is unexpected movement
No movement If there is no unexpected movement

Outcome Measures

Primary Outcome Measures

Predictive factors of unpredicted movement [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Bundang-gu	Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT03489785

Other Study ID Numbers:

B-1801-444-102

First Posted:

Apr 5, 2018

Last Update Posted:

Apr 30, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Seoul National University Hospital

Predicted factor

Motor Evoked Potentials

Additional relevant MeSH terms:

Dyskinesias

Study Results

No Results Posted as of Apr 30, 2018