Motor Evoked Potentials and SedLine

Terminated

• Conditions: Spine Surgery

• Registration Number: NCT00805844
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Motor Evoked Potential (MEP) monitoring during spine surgery is now used routinely. However it is affected by a variety of anesthetics including fluctuating and/or excessively deep or light levels of anesthesia. A common problem is maintaining an overall constancy and adequacy of anesthesia. Individual patients' responses to anesthesia can differ greatly from population means and can complicate the interpretation of MEPs. False alarms can have significant consequences. One strategy to minimize the anesthetic induced variability of MEPs, and thereby improve the monitoring overall, is to keep the patient's anesthetic state (or "depth") in a narrow range during surgery. This study tests whether using a commercially available depth of anesthesia monitor in addition to usual clinical practice improves the quality of MEPs.

The hypothesis of this study is that the SedLine Monitor, which uses an EEG derived assessment of anesthetic depth, may facilitate MEP monitoring if it is kept within a narrow range during spine surgery. Because SedLine recommends maintaining their Index between 30 and 40 during surgical anesthesia, this is the range used in the primary hypothesis.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-12-09
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Primary Completion: 2009-07
• Study Completion: 2009-09
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-13
• Last Update Posted: 2011-07-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients undergoing corrective spinal procedures, for whom MEP monitoring has been requested by the surgeon.
• 18 yrs of age or older

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Exclusion Criteria

• Minors, prisoners and those unable to consent for themselves.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary outcomes include i) Stimulation threshold ii) MEP fade index and iii) Facilitation necessity and stability.	end of study

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States