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

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.

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Key information

Conditions

Anesthesia, General

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18-45 years of age
Body mass index (BMI) lower or equal to 25 m2/kg
Subjects must be able to comprehend spoken and written English

Exclusion criteria

Any type of psychiatric, neurological, or neuromuscular disorder
Thyroid disease
History of smoking
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?
Allergy to study medication (propofol), soy, or egg proteins.
History of drug abuse
Chronic or acute use of opioids, or other medications affecting the CNS
Pregnancy

Treatment and study plan

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

Device

Propofol

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: May 26, 2008
Registry last updated: Nov 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed