ADVANCE: Assessment for Defining Variability in Anesthesia Through Novel Clinical EEG

Completed

Conditions studied: Pain

In brief

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 heart rate, tearing, etc.) to stimulation (pain) and to determine whether these intraoperative findings are related to patient-assessed postoperative pain scores. The hypothesis is that increases in these variability measures are associated with increased probability of unwanted responses. If confirmed, these variability measures may help anesthesia providers by highlighting periods of inadequate analgesia (pain relief).

Key facts

Study ID

NCT00689130

Run by

Medtronic - MITG

People needed

120

Starts

2008-05-01

Expected to finish

2008-10-01

Last updated by the study team

2012-03-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Emory University School of Medicine — Atlanta, Georgia, United States
• University of Louisville — Louisville, Kentucky, United States
• Saint Vincent Catholic Medical Center — New York, New York, United States
• Hospital Sanitas La Moraleja Sanchinarro — Madrid, Spain

Full record on ClinicalTrials.gov

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