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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Interventions

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ReinLoop control software for patient-specific induction and maintenance of anesthesia

Intervention Type DEVICE

Propofol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Doufas

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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13305

Identifier Type: -

Identifier Source: secondary_id

SU-05062008-1141