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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01778608
Enrollment
20
Registered
2013-01-29
Start date
2012-01-31
Completion date
2012-04-30
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious Sedation

Keywords

Sedation

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.

Interventions

None listed

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 72 Years
Healthy volunteers
No

Inclusion criteria

* age 50-72 years

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Response timesContinuously shortly before (baseline)Response time between non-noxious stimulus and activation of handset device
response timeduring induction of anesthesiaResponse time between non-noxious stimulus and activation of handset device

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026