Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
MMRF Struys, University Medical Centre Groningen Identifier:
First received: May 31, 2012
Last updated: May 25, 2013
Last verified: May 2013
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.

Conscious Sedation

Study Type: Observational
Study Design: 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

Further study details as provided by University Medical Center Groningen:

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

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

Enrollment: 20
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01778608

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

Responsible Party: MMRF Struys, Prof. Dr. MMRF Struys, Department Head, University Medical Centre Groningen Identifier: NCT01778608     History of Changes
Other Study ID Numbers: PCS-001
Study First Received: May 31, 2012
Last Updated: May 25, 2013

Keywords provided by University Medical Center Groningen:

Additional relevant MeSH terms:
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 23, 2017