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

This study is currently recruiting participants.

Verified by Stanford University, November 2008

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00683956

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.

Condition	Intervention	Phase
Anesthesia, General	Device: ReinLoop control software for patient-specific induction and maintenance of anesthesia Drug: Propofol	Phase I

MedlinePlus related topics: Anesthesia

Drug Information available for: Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Dose Comparison, Single Group Assignment, Efficacy Study
Official Title:	Evaluation of a Closed-Loop Control System for Patient-Specific Induction and Maintenance of Propofol Hypnosis

Further study details as provided by Stanford University:

Primary Outcome Measures:

To evaluate the clinical efficacy of the ReinLoop agent in delivering closed-loop, patient-specific hypnosis.

Estimated Enrollment:	35
Study Start Date:	May 2008

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683956

Contacts

Contact: Anthony Doufas, MD

(650) 498-7699

agdoufas@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Anthony Doufas, MD 650-498-7699 agdoufas@stanford.edu
Principal Investigator: Anthony Doufas
Sub-Investigator: Vivek Kulkarni

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Anthony Doufas

Stanford University

More Information

Study ID Numbers:	SU-05062008-1141, 13305
Study First Received:	May 22, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00683956
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009