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Motor Evoked Potentials and SedLine
This study is currently recruiting participants.
Verified by University of California, San Francisco, December 2008
First Received: December 9, 2008   No Changes Posted
Sponsored by: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00805844
  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

MedlinePlus related topics: Anesthesia Surgery
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 70
Study Start Date: September 2008
Estimated Primary Completion Date: March 2010 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805844

Contacts
Contact: Adrian W Gelb, MBChB 4154760120 gelba@anesthesia.ucsf.edu

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Adrian W Gelb, MBChB     415-476-0120     gelba@anesthesia.ucsf.edu    
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: UCSF ( Adrian W Gelb, Professor )
Study ID Numbers: H50805-31889
Study First Received: December 9, 2008
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00805844     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Anesthetics

ClinicalTrials.gov processed this record on May 07, 2009