Evaluation of a Closed-Loop Control System for Patient-Specific Induction and Maintenance of Propofol Hypnosis

Stanford University1 site in 1 country35 target enrollmentMay 2008

ConditionsAnesthesia, General

DrugsPropofol

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Anesthesia, General
Sponsor: Stanford University
Enrollment: 35
Locations: 1
Primary Endpoint: To evaluate the clinical efficacy of the ReinLoop agent in delivering closed-loop, patient-specific hypnosis.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

September 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Sponsor

Eligibility Criteria

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