Anesthesia and Motor Evoked Potential (MEP) Recruitment

September 18, 2020 updated by: Children's Hospital Medical Center, Cincinnati

The Effect of Anesthesia on the Recruitment of Motor Evoked Potentials Using an Increased Number of Pulses

Test the hypothesis to recruit larger motor responses to transcranial stimulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is designed to test the hypothesis that it is possible to recruit larger motor responses to transcranial stimulation by increasing the number of stimulating pulses under both baseline conditions and conditions of increased anesthetic suppression of the motor responses.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 12 through 17 years
  • Diagnosis of idiopathic scoliosis
  • Scheduled for posterior spinal fusion with neurophysiological monitoring
  • No known allergies to propofol or remifentanil
  • No contraindication to total intravenous anesthesia
  • No contraindications to the administration of volatile agents

Exclusion Criteria:

  • Failure to consent or assent to study
  • Diagnosis other than idiopathic scoliosis
  • Poorly controlled seizures or the presence of a cochlear implant
  • Patient history or family history of malignant hypothermia or mitochondrial myopathies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: desflurane MEP's
Transcranial motor evoked potentials are obtained under total intravenous anesthesia (TIVA) and again after desflurane at 3%, for at least 5 minutes.at two different time points. Each subject is his/her own control
Drug: Desflurane
Other Names:
  • Suprane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Pulse Train Length on Transcranial Motor Evoked Potentials (TcMEP) Area Under Total Intravenous Anesthesia (TIVA) and TIVA Plus 3% Desflurane
Time Frame: 15 minutes
A series of 15 transcranial motor evoked potentials are recorded under a TIVA anesthetic and again after addition of 3% desflurane for 5 minutes at two different time points in a surgical procedure. The series consisted of 3 runs of 5,6, 7, 8, and 9 pulse trains, each train separated by 30 seconds. The 3 runs were averaged to give and average value of TcMEP amplitude and area for the 5,6,7,8 and 9 pulse trains. The data were used to compute regression coefficients for area vs pulse length for the TIVA case and TIVA plus desflurane for each participant who completed the study..The final measure is the number of participants who had a MEP area ratios significantly different from 1 at all times and conditions; that is for TIVA alone and TIVA plus desflurane, at both time points.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

July 22, 2014

First Posted (Estimate)

July 24, 2014

Study Record Updates

Last Update Posted (Actual)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 18, 2020

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-1065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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