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

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683956
• Other study ID #: SU-05062008-1141
• Secondary ID: 13305
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2008
• Last updated: November 22, 2011
• Start date: May 2008
• Est. completion date: September 2009

Study information

• Verified date: November 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

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

Drug:
• Propofol

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the clinical efficacy of the ReinLoop agent in delivering closed-loop, patient-specific hypnosis.