NCT00683956

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

Enrollment Period

1.2 years

First QC Date

May 22, 2008

Last Update Submit

November 22, 2011

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

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

Interventions

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

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Anthony Doufas

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 26, 2008

Study Start

May 1, 2008

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

November 24, 2011

Record last verified: 2011-11

Locations

US(1)