Motor Evoked Potentials and SedLine
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Purpose
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.
| Condition |
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Spine Surgery |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Monitoring Depth of Anesthesia With the SedLine Facilitates Motor Evoked Potential (MEP) Monitoring During Corrective Spinal Surgery |
- 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 [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Secondary outcomes include i) Stimulation threshold ii) MEP fade index and iii) Facilitation necessity and stability. [ Time Frame: end of study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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1
Spine surgery with Motor Evoked Potential monitoring without SedLine monitoring visible.
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2
Spine surgery with Motor Evoked Potential Monitoring with SedLine monitoring visible.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients undergoing corrective spinal procedures, for whom MEP monitoring has been requested by the surgeon.
Inclusion Criteria:
- Patients undergoing corrective spinal procedures, for whom MEP monitoring has been requested by the surgeon.
- 18 yrs of age or older
Exclusion Criteria:
- Minors, prisoners and those unable to consent for themselves.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Adrian W Gelb, Professor, UCSF |
| ClinicalTrials.gov Identifier: | NCT00805844 History of Changes |
| Other Study ID Numbers: | H50805-31889 |
| Study First Received: | December 9, 2008 |
| Last Updated: | July 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
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Spine Motor Evoked Potentials |
ClinicalTrials.gov processed this record on May 23, 2013