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Motor Evoked Potentials and SedLine

This study has been terminated.
(Sponsor terminated the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00805844
First Posted: December 10, 2008
Last Update Posted: July 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, San Francisco
  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
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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Secondary outcomes include i) Stimulation threshold ii) MEP fade index and iii) Facilitation necessity and stability. [ Time Frame: end of study ]

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
1
Spine surgery with Motor Evoked Potential monitoring without SedLine monitoring visible.
2
Spine surgery with Motor Evoked Potential Monitoring with SedLine monitoring visible.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing corrective spinal procedures, for whom MEP monitoring has been requested by the surgeon.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805844


Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
  More Information

Responsible Party: Adrian W Gelb, Professor, UCSF
ClinicalTrials.gov Identifier: NCT00805844     History of Changes
Other Study ID Numbers: H50805-31889
First Submitted: December 9, 2008
First Posted: December 10, 2008
Last Update Posted: July 15, 2011
Last Verified: July 2011

Keywords provided by University of California, San Francisco:
Spine
Motor Evoked Potentials