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Motor Evoked Potentials and SedLine

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Terminated

Conditions

Spine Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT00805844
H50805-31889

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

70 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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