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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01778608
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : May 29, 2013
Information provided by (Responsible Party):
MMRF Struys, University Medical Center Groningen

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
Conscious Sedation

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 : January 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Primary Outcome Measures :
  1. Response times [ Time Frame: Continuously shortly before (baseline) ]
    Response time between non-noxious stimulus and activation of handset device

  2. response time [ Time Frame: during induction of anesthesia ]
    Response time between non-noxious stimulus and activation of handset device

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Ages Eligible for Study:   50 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Twenty patients requiring anaesthesia for clinical surgical care. ASA physical status I, II or III

Inclusion Criteria:

  • age 50-72 years

Exclusion Criteria:

  • volunteer refusal
  • patient age >72 years
  • significant cardiovascular or respiratory disease
  • latex allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01778608

University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen

Responsible Party: MMRF Struys, Prof. Dr. MMRF Struys, Department Head, University Medical Center Groningen Identifier: NCT01778608     History of Changes
Other Study ID Numbers: PCS-001
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by MMRF Struys, University Medical Center Groningen:

Additional relevant MeSH terms:
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms