Evaluation of a Closed-Loop Control System for Administering Patient-Specific Anesthesia
Trial ID or NCT#
NCT00683956
Status
NOT RECRUITING
Purpose
Numerous efforts have focused on the development of closed-loop systems to control anesthesia using the electrical activity of the brain (EEG) and EEG-based parameters as surrogate measures of anesthetic depth. New systems have been recently developed to considerably improve anesthetic control using model-based, patient-adaptive methods. The purpose of this study is to evaluate the clinical efficacy of a new intelligent software, ReinLoop, in delivering closed-loop, patient-specific hypnosis.
Official Title
Evaluation of a Closed-Loop Control System for Patient-Specific Induction and Maintenance of Propofol Hypnosis
Eligibility Criteria
Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- 1. 18-45 years of age 2. Body mass index (BMI) lower or equal to 25 m2/kg 3. Subjects must be able to comprehend spoken and written English
Exclusion Criteria:
- 1. Any type of psychiatric, neurological, or neuromuscular disorder 2. Thyroid disease 3. History of smoking 4. Alcohol consumption which exceeds 2 drinks per day and /or drug abuse. Volunteers will be asked the question: How many drinks are you drinking on your typical day? 5. Allergy to study medication (propofol), soy, or egg proteins. 6. History of drug abuse 7. Chronic or acute use of opioids, or other medications affecting the CNS 8. Pregnancy
Investigator(s)
Anthony G. Doufas, M.D., Ph.D.
Anesthesiologist
Professor of Anesthesiology, Perioperative and Pain Medicine
View on ClinicalTrials.gov
