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

Conscious Sedation Clinical Trial

Official title:

Feasibility Test of a Handset Device to Detect Sedation Levels and Loss of Consciousness During Propofol Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778608
• Other study ID #: PCS-001
• Status: Completed
• Start date: January 2012
• Est. completion date: April 2012

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 72 Years

Eligibility

Inclusion Criteria:

• age 50-72 years

Exclusion Criteria:

• volunteer refusal

• patient age >72 years

• significant cardiovascular or respiratory disease

• latex allergy

Related Conditions & MeSH terms

• Conscious Sedation
• Unconsciousness

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response times	Response time between non-noxious stimulus and activation of handset device	Continuously shortly before (baseline)
Primary	response time	Response time between non-noxious stimulus and activation of handset device	during induction of anesthesia