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临床试验/NCT01778608
NCT01778608已完成不适用

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

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
response time

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 50-72 years

排除标准

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

结局指标

主要结局

response time

时间窗: during induction of anesthesia

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

Response times

时间窗: Continuously shortly before (baseline)

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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