Evaluation of a Closed-Loop Control System for Administering Patient-Specific Anesthesia
Phase 1
Completed
- Conditions
- Anesthesia, General
- Registration Number
- NCT00683956
- Lead Sponsor
- Stanford University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- 18-45 years of age
- Body mass index (BMI) lower or equal to 25 m2/kg
- Subjects must be able to comprehend spoken and written English
Exclusion Criteria
- Any type of psychiatric, neurological, or neuromuscular disorder
- Thyroid disease
- History of smoking
- 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?
- Allergy to study medication (propofol), soy, or egg proteins.
- History of drug abuse
- Chronic or acute use of opioids, or other medications affecting the CNS
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the clinical efficacy of the ReinLoop agent in delivering closed-loop, patient-specific hypnosis.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Stanford University School of Medicine
🇺🇸Stanford, California, United States