Back to resultsMEP and Neuromuscular Blocker
Primary Purpose
Brain Tumor
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Arm I (MEP)
Sponsored by
About this trial
This is an interventional supportive care trial for Brain Tumor
Eligibility Criteria
Inclusion Criteria:
1. Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective brain tumor surgery under the monitoring of the motor evoked potential
Exclusion Criteria:
- Central or peripheral neuromuscular disease
- Sensory or motor nerve disorder
- Allergy to propofol, remifentanil, and rocuronium
- Patients with pacemaker
Sites / Locations
- GangnamSeverance Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rocuronium
Arm Description
Neuromuscular blockade will be performed using rocuronium.
Outcomes
Primary Outcome Measures
Amplitude of the motor evoked potential
Amplitude of the motor evoked potential will be evaluated at intraoperative 0 h from the start of the anesthetic induction.
Secondary Outcome Measures
Amplitude of the motor evoked potential
Amplitude of the motor evoked potential will be evaluated at intraoperative 0 h from the opening of the dura.
Full Information
NCT ID
NCT04768400
First Posted
February 17, 2021
Last Updated
June 4, 2023
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04768400
Brief Title
MEP and Neuromuscular Blocker
Official Title
Quantitative Analysis Between Neuromuscular Blocking Agent and Motor Evoked Potential and Analysis of Risk Factors for the Coefficient of Variance of Motor Evoked Potential in Patients Undergoing Brain Tumor Removal Surgery: Population Approach
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
May 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is important to predict the influence of the neuromuscular blocking agents on the motor evoked potential. Investigator will investigate the dose-response relationship between the degree of the neuromuscular blockade and the motor evoked potential in patients undergoing brain tumor surgery using the population approach. Investigator will investigate the influence of the other factors such as the impedence, reactance, muscel amount, and age on the motor evoked potential.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rocuronium
Arm Type
Experimental
Arm Description
Neuromuscular blockade will be performed using rocuronium.
Intervention Type
Drug
Intervention Name(s)
Arm I (MEP)
Intervention Description
Arm I (MEP): Motor evoked potential will be measured in various degree of the neuromuscular blockade.
Primary Outcome Measure Information:
Title
Amplitude of the motor evoked potential
Description
Amplitude of the motor evoked potential will be evaluated at intraoperative 0 h from the start of the anesthetic induction.
Time Frame
At intraoperative 0 hr from the start of the anesthetic induction
Secondary Outcome Measure Information:
Title
Amplitude of the motor evoked potential
Description
Amplitude of the motor evoked potential will be evaluated at intraoperative 0 h from the opening of the dura.
Time Frame
At intraoperative 0 h from the opening of the dura
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective brain tumor surgery under the monitoring of the motor evoked potential
Exclusion Criteria:
Central or peripheral neuromuscular disease
Sensory or motor nerve disorder
Allergy to propofol, remifentanil, and rocuronium
Patients with pacemaker
Facility Information:
Facility Name
GangnamSeverance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
MEP and Neuromuscular Blocker
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