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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00683956

Enrollment

Registered

2008-05-26

Start date

2008-05-31

Completion date

2009-09-30

Last updated

2011-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General

Brief summary

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.

Interventions

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

DRUGPropofol

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026