Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients
1 other identifier
interventional
30
1 country
1
Brief Summary
When patients have spinal surgery, electrodes are placed on the body to measure motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP). Many hospitals only use IV anesthesia because they feel that measuring MEP and SSEP is easier using IV anesthesia. At this hospital the investigators typically use inhaled anesthesia and are able to successfully measure MEP and SSEP. This is a study to find out if one method of anesthesia is better than the other for measuring MEP and SSEP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
1 active site
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
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 7, 2012
CompletedFirst Posted
Study publicly available on registry
March 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
February 26, 2015
CompletedFebruary 26, 2015
February 1, 2015
1.2 years
March 7, 2012
February 4, 2015
February 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Amplitude Required to Elicit the MEP
Compare the data obtained from neuromonitoring including the amplitude required to elicit the MEP from patients receiving general anesthesia with an inhalational anesthetic agent to those receiving total intravenous anesthesia (TIVA).
at time of surgery
Secondary Outcomes (2)
Amplitude of the SSEPs
day of surgery
Latency of the SSEP's
day of surgery
Study Arms (2)
Total intravenous anesthesia (TIVA)
ACTIVE COMPARATORInhaled anesthesia
ACTIVE COMPARATORInterventions
Propofol adjusted to maintain the bispectral index at 40-60.
Desflurane adjusted to maintain the bispectral index at 40-60.
Eligibility Criteria
You may qualify if:
- Patients with idiopathic scoliosis.
You may not qualify if:
- Patients with neuromuscular scoliosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Martin, MD
- Organization
- Nationwide Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph D Tobias, MD
Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman, Dept. of Anesthesiology & Pain Medicine
Study Record Dates
First Submitted
March 7, 2012
First Posted
March 9, 2012
Study Start
January 1, 2012
Primary Completion
April 1, 2013
Study Completion
June 1, 2013
Last Updated
February 26, 2015
Results First Posted
February 26, 2015
Record last verified: 2015-02