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

NCT01778608 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-04-18

No results posted yet for this study

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.

Conditions

  • Conscious Sedation

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Eligibility

Min Age
50 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01778608 on ClinicalTrials.gov