Motor Evoked Potentials and SedLine

This study has been terminated.
(Sponsor terminated the study)
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00805844
First received: December 9, 2008
Last updated: July 13, 2011
Last verified: July 2011
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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:
Spine
Motor Evoked Potentials

ClinicalTrials.gov processed this record on August 28, 2014