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

Stanford University35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Anesthesia, General

Interventions

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

PropofolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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