NCT04768400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

March 9, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2022

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

February 17, 2021

Last Update Submit

June 4, 2023

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Amplitude of the motor evoked potential

    At intraoperative 0 h from the opening of the dura

Study Arms (1)

rocuronium

EXPERIMENTAL

Neuromuscular blockade will be performed using rocuronium.

Drug: Arm I (MEP)

Interventions

Arm I (MEP)DRUG

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

rocuronium

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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

You may not qualify if:

  • Central or peripheral neuromuscular disease
  • Sensory or motor nerve disorder
  • Allergy to propofol, remifentanil, and rocuronium
  • Patients with pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 24, 2021

Study Start

March 9, 2021

Primary Completion

May 13, 2022

Study Completion

May 13, 2022

Last Updated

June 6, 2023

Record last verified: 2023-06

Locations

KR(1)