- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02199314
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
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
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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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
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Other Names:
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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
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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.
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15 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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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