Expired Study
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Stanford, California 94305


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.


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


Study is Available At:


Original ID:

SU-05062008-1141


NCT ID:

NCT00683956


Secondary ID:

13305


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

35


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Anthony Doufas
Principal Investigator
Stanford University

Study Dates

Start Date:May 2008
Completion Date:September 2009
Completion Type:Actual
Primary Completion Date:July 2009
Primary Completion Type:Actual
Verification Date:November 2011
Last Changed Date:November 22, 2011
First Received Date:May 22, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:To evaluate the clinical efficacy of the ReinLoop agent in delivering closed-loop, patient-specific hypnosis.
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:ReinLoop control software for patient-specific ind
Intervention Type:Drug
Name:Propofol

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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