Motor Evoked Potentials and SedLine

Monitoring Depth of Anesthesia With the SedLine Facilitates Motor Evoked Potential (MEP) Monitoring During Corrective Spinal Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Spine Surgery

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.

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing corrective spinal procedures, for whom MEP monitoring has been requested by the surgeon.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Spine surgery with Motor Evoked Potential monitoring without SedLine monitoring visible.
2; Spine surgery with Motor Evoked Potential Monitoring with SedLine monitoring visible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: December 9, 2008
• First Submitted That Met QC Criteria: December 9, 2008
• First Posted (Estimate): December 10, 2008

Study Record Updates

• Last Update Posted (Estimate): July 15, 2011
• Last Update Submitted That Met QC Criteria: July 13, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Spine; Motor Evoked Potentials
• Other Study ID Numbers: H50805-31889