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