Incidence of Recall After Procedural Sedation With Propofol in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 4
- 主要终点
- Recall incidence
研究概览
简要总结
The purpose of this study is to determine the incidence of recall in patients managed in emergency department with a procedural sedation protocol using propofol in a population of 250 .
详细描述
After procedural sedation for fracture or joint dislocation reduction using propofol, adult patients recall will be assessed with a standardised form. This recall assessment will be realised 2 hours (+/- 15 minutes) after the procedural sedation and the day after.
The primary outcome measure will be the recall incidence 2 hours (+/- 15 minutes) after a procedural sedation. A secondary outcome will be the recall incidence one day after the procedural sedation.
The recall will be defined by a positive answer to the third question of the Sandin form (Lancet. 2000;355(9205):707-11).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients (> 18 years old) who had a procedural sedation in emergency department using propofol for fracture or joint dislocation reduction
- •Patients who received an initial injection of Propofol by slow intravenous injection of 1 mg/kg in 20 seconds
- •Inclusion less than 2 hours from the injection of Propofol
- •Patients who have signed a consent to participate in the study
- •Patients covered by social security.
排除标准
- •Patients under 18 years old
- •Patients who cannot signed the informed consent
- •Patients who had procedural sedation using other drugs that propofol
- •Participation in another study type biomedical research
研究组 & 干预措施
Dislocation reduction using propofol
结局指标
主要结局
Recall incidence
时间窗: At 2 hours (+/- 15 minutes) after procedural sedation with propofol
questionnaire of Brice amended by Sandin
次要结局
- Recall incidence(About 24 hours after procedural sedation with propofol)
- Patient's satisfaction assessment(At 2 hours (+/- 15 minutes) after procedural sedation with propofol)