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MEP and Neuromuscular Blocker

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04768400
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Dong Woo Han, Gangnam Severance Hospital

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.

Condition or disease Intervention/treatment Phase
Brain Tumor Drug: Arm I (MEP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : March 9, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: rocuronium
Neuromuscular blockade will be performed using rocuronium.
Drug: Arm I (MEP)
Arm I (MEP): Motor evoked potential will be measured in various degree of the neuromuscular blockade.




Primary Outcome Measures :
  1. Amplitude of the motor evoked potential [ Time Frame: At intraoperative 0 hr from the start of the anesthetic induction ]
    Amplitude of the motor evoked potential will be evaluated at intraoperative 0 h from the start of the anesthetic induction.


Secondary Outcome Measures :
  1. Amplitude of the motor evoked potential [ Time Frame: At intraoperative 0 h from the opening of the dura ]
    Amplitude of the motor evoked potential will be evaluated at intraoperative 0 h from the opening of the dura.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  1. Central or peripheral neuromuscular disease
  2. Sensory or motor nerve disorder
  3. Allergy to propofol, remifentanil, and rocuronium
  4. Patients with pacemaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04768400


Contacts
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Contact: Dong woo Han 82-2-2224-3919 hanesth@yuhs.ac

Locations
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Korea, Republic of
GangnamSeverance Hospital Recruiting
Seoul, Korea, Republic of
Contact: DongWoo DongWoo    82-2-2019-4601    gsirb@yuhs.ac   
Contact: DongWoo DongWoo    82-2-2019- ext 2740      
Sponsors and Collaborators
Gangnam Severance Hospital
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Responsible Party: Dong Woo Han, Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT04768400    
Other Study ID Numbers: 3-2020-0511
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases