ADVANCE: Assessment for Defining Variability in Anesthesia Through Novel Clinical EEG (NCT00689130) | Clinical Trial Compass
CompletedNot Applicable
ADVANCE: Assessment for Defining Variability in Anesthesia Through Novel Clinical EEG
United States, Spain120 participantsStarted 2008-05
Plain-language 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 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).
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.