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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MMRF Struys, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01778608
First received: May 31, 2012
Last updated: May 25, 2013
Last verified: May 2013
  Purpose

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
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 Centre Groningen:

Primary Outcome Measures:
  • Response times [ Time Frame: Continuously shortly before (baseline) ] [ Designated as safety issue: No ]
    Response time between non-noxious stimulus and activation of handset device

  • response time [ Time Frame: during induction of anesthesia ] [ Designated as safety issue: No ]
    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)
  Eligibility

Ages Eligible for Study:   50 Years to 72 Years
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • age 50-72 years

Exclusion Criteria:

  • volunteer refusal
  • patient age >72 years
  • significant cardiovascular or respiratory disease
  • latex allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778608

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

No publications provided

Responsible Party: MMRF Struys, Prof. Dr. MMRF Struys, Department Head, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01778608     History of Changes
Other Study ID Numbers: PCS-001
Study First Received: May 31, 2012
Last Updated: May 25, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
Sedation

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

ClinicalTrials.gov processed this record on April 17, 2014