Motor Evoked Potentials and SedLine

Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00805844
• Other study ID #: H50805-31889
• Status: Terminated
• Phase: N/A
• First received: December 9, 2008
• Last updated: July 13, 2011
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: July 2011
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spine Surgery

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary outcomes include i) Stimulation threshold ii) MEP fade index and iii) Facilitation necessity and stability.		end of study	No