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NCT04768400 Clinical Trial

MEP and Neuromuscular Blocker

Brain Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04768400
Other study ID # 3-2020-0511
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 9, 2021
Est. completion date May 13, 2022

Study information
Verified date June 2023
Source Gangnam Severance Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date May 13, 2022
Est. primary completion date May 13, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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: 1. Central or peripheral neuromuscular disease 2. Sensory or motor nerve disorder 3. Allergy to propofol, remifentanil, and rocuronium 4. Patients with pacemaker

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Arm I (MEP)
Arm I (MEP): Motor evoked potential will be measured in various degree of the neuromuscular blockade.

Locations
Country Name City State
Korea, Republic of GangnamSeverance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. At intraoperative 0 hr from the start of the anesthetic induction
Secondary 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. At intraoperative 0 h from the opening of the dura
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