Motor Evoked Potentials and SedLine

NCT ID: NCT00805844

Last Updated: 2011-07-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-09-30

Brief Summary

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.

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.

Conditions

Spine Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Spine surgery with Motor Evoked Potential monitoring without SedLine monitoring visible.

No interventions assigned to this group

2

Spine surgery with Motor Evoked Potential Monitoring with SedLine monitoring visible.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

UCSF

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

H50805-31889

Identifier Type: -

Identifier Source: org_study_id