Status:
COMPLETED
ADVANCE: Assessment for Defining Variability in Anesthesia Through Novel Clinical EEG
Lead Sponsor:
Medtronic - MITG
Conditions:
Pain
Eligibility:
All Genders
18-80 years
Brief Summary
The present study is designed to compare prospectively whether sBIS, sEMG, or CVI variability (brain monitoring) can be used to predict unwanted intraoperative responses (high blood pressure, fast hea...
Detailed Description
Anesthesia providers have been using processed EEG parameters (brain monitors) to assess the depth of anesthesia for many years. The Bispectral Index (BIS®; Aspect Medical Systems, Inc.), one such bra...
Eligibility Criteria
Inclusion
- Age range 18-80 years old
- ASA I through III
- Scheduled for elective, non-cardiac surgery under General Anesthesia
- Ability to understand and perform all recovery assessments and procedures
Exclusion
- Subjects with known neurological disorders, including current use of anticonvulsant medications.
- Subjects with uncontrolled hypertension or other serious medical conditions which would interfere with cardiovascular responses analysis. Subjects on anti-arrhythmics, beta-blockers, or other agents which may reduce the cardiovascular responsiveness to pain and surgical stress.
- Patients with any contraindications to the selected anesthetic agents specified for each site.
- Alcohol or illicit drug use which prevents normal functioning in society or has lead to organ toxicity. Chronic use of opioids, narcotics or analgesics which may limit a subject's responsiveness to analgesic dosages.
- Significant hypotension (systolic BP \< 100) or bradycardia (HR \< 55) during baseline assessment.
- Anticipated or planned regional block or extensive local anesthetic for post-operative pain control.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00689130
Start Date
May 1 2008
End Date
October 1 2008
Last Update
March 7 2012
Active Locations (4)
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1
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
2
University of Louisville
Louisville, Kentucky, United States, 40202
3
Saint Vincent Catholic Medical Center
New York, New York, United States, 10011
4
Hospital Sanitas La Moraleja Sanchinarro
Madrid, Spain