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Anesthesia and Motor Evoked Potential (MEP) Recruitment

Primary Purpose

Idiopathic Scoliosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Desflurane
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Idiopathic Scoliosis focused on measuring intra, operative, neurophysiologic, monitoring, transcranial, motor, evoked, potential, anesthesia, pulses

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

desflurane MEP's

Arm Description

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

Outcomes

Primary Outcome Measures

Effect of Pulse Train Length on Transcranial Motor Evoked Potentials (TcMEP) Area Under Total Intravenous Anesthesia (TIVA) and TIVA Plus 3% Desflurane
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.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2014
Last Updated
September 18, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT02199314
Brief Title
Anesthesia and Motor Evoked Potential (MEP) Recruitment
Official Title
The Effect of Anesthesia on the Recruitment of Motor Evoked Potentials Using an Increased Number of Pulses
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Scoliosis
Keywords
intra, operative, neurophysiologic, monitoring, transcranial, motor, evoked, potential, anesthesia, pulses

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
desflurane MEP's
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Desflurane
Other Intervention Name(s)
Suprane
Primary Outcome Measure Information:
Title
Effect of Pulse Train Length on Transcranial Motor Evoked Potentials (TcMEP) Area Under Total Intravenous Anesthesia (TIVA) and TIVA Plus 3% Desflurane
Description
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.
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Anesthesia and Motor Evoked Potential (MEP) Recruitment

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