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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00683956
First received: May 22, 2008
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Official Title: Evaluation of a Closed-Loop Control System for Patient-Specific Induction and Maintenance of Propofol Hypnosis

Resource links provided by NLM:

Drug Information available for: Propofol
U.S. FDA Resources

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
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
  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

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Anthony Doufas Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00683956     History of Changes
Other Study ID Numbers: SU-05062008-1141, 13305
Study First Received: May 22, 2008
Last Updated: November 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 19, 2013