Evaluation of a Closed-Loop Control System for Administering Patient-Specific Anesthesia

Stanford University

Status and phase: Completed; Phase 1

Conditions: Anesthesia, General

Treatments: Device: ReinLoop control software for patient-specific induction and maintenance of anesthesia; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT00683956

13305

SU-05062008-1141

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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