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

NCT01778608 | Completed

• 1 other identifier: PCS-001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Conscious Sedation

Keywords

Sedation

Outcome Measures

Primary Outcomes (2)

• Response times

  Response time between non-noxious stimulus and activation of handset device

  Continuously shortly before (baseline)

• response time

  Response time between non-noxious stimulus and activation of handset device

  during induction of anesthesia

Eligibility Criteria

• Age: 50 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty patients requiring anaesthesia for clinical surgical care. ASA physical status I, II or III

You may qualify if:

• age 50-72 years

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: January 29, 2013
• Study Start: January 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

NL (1)