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Feasability Test of a Handset Device to Detect Levels of Sedation and Loss of Consciousness

Sponsor
University Medical Center Groningen (Other)
Overall Status
Completed
CT.gov ID
NCT01778608
Collaborator
(none)
20
Enrollment
1
Location
3
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sedation is often administered to relieve anxiety and discomfort during uncomfortable procedures in elderly patients. Patient control of sedation offers many potential benefits for patients and healthcare professionals, including improved safety and patient satisfaction. The investigators overall goal is to develop a patient controlled intravenous sedation system that is effective but very safe for the patient, and requires minimal supervision by a doctor or nurse. To fulfill these criteria, a sedation system should incorporate fail-safe safety mechanisms. A key safety-critical component is a method of objectively assessing the degree of sedation of the patient, and of preventing him from self-administering unsafe doses of the sedative drug. The investigators have designed a new sedation system that uses a measure of the speed of response of the patient to a defined non-noxious stimulus to determine whether or not it is safe to allow him to self-administer further levels of sedation. Before being able to execute a volunteer study in order to determine a rational selection of optimal threshold response time, a feasibility test on the handset device is required.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Feasibility Test of a Handset Device to Detect Sedation Levels and Loss of Consciousness During Propofol Administration
    Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2012
    Actual Study Completion Date :
    Apr 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. Response times [Continuously shortly before (baseline)]

      Response time between non-noxious stimulus and activation of handset device

    2. response time [during induction of anesthesia]

      Response time between non-noxious stimulus and activation of handset device

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 72 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age 50-72 years
    Exclusion Criteria:

    • volunteer refusal

    • patient age >72 years

    • significant cardiovascular or respiratory disease

    • latex allergy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Groningen Groningen Netherlands 9700 RB

    Sponsors and Collaborators

    • University Medical Center Groningen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MMRF Struys, Prof. Dr. MMRF Struys, Department Head, University Medical Center Groningen
    ClinicalTrials.gov Identifier:
    NCT01778608
    Other Study ID Numbers:
    • PCS-001
    First Posted:
    Jan 29, 2013
    Last Update Posted:
    May 29, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by MMRF Struys, Prof. Dr. MMRF Struys, Department Head, University Medical Center Groningen
    Sedation
    Additional relevant MeSH terms:
    Unconsciousness

    Study Results

    No Results Posted as of May 29, 2013