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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

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