Study Stopped
Sponsor terminated the study
Motor Evoked Potentials and SedLine
Monitoring Depth of Anesthesia With the SedLine Facilitates Motor Evoked Potential (MEP) Monitoring During Corrective Spinal Surgery
1 other identifier
observational
70
1 country
1
Brief Summary
To determine if using usual clinical practice plus a depth of anesthesia monitor, SedLine, to guide anesthetic administration improves the quality and ease of MEP monitoring in patients undergoing corrective spinal procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2008
Shorter than P25 for all trials
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
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 9, 2008
CompletedFirst Posted
Study publicly available on registry
December 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedJuly 15, 2011
July 1, 2011
10 months
December 9, 2008
July 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome of this study is a composite measure of the motor evoked responses over the duration of the surgical procedure utilizing the "area under the curve" (AUC, volt-seconds) of the response time series
End of study
Secondary Outcomes (1)
Secondary outcomes include i) Stimulation threshold ii) MEP fade index and iii) Facilitation necessity and stability.
end of study
Study Arms (2)
1
Spine surgery with Motor Evoked Potential monitoring without SedLine monitoring visible.
2
Spine surgery with Motor Evoked Potential Monitoring with SedLine monitoring visible.
Eligibility Criteria
Patients undergoing corrective spinal procedures, for whom MEP monitoring has been requested by the surgeon.
You may qualify if:
- Patients undergoing corrective spinal procedures, for whom MEP monitoring has been requested by the surgeon.
- yrs of age or older
You may not qualify if:
- Minors, prisoners and those unable to consent for themselves.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Francisco
San Francisco, California, 94143, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 9, 2008
First Posted
December 10, 2008
Study Start
September 1, 2008
Primary Completion
July 1, 2009
Study Completion
September 1, 2009
Last Updated
July 15, 2011
Record last verified: 2011-07