Incidence of Recall After Procedural Sedation With Propofol in the Emergency Department (MEMOPROPO)
研究概览
详细说明
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).
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
La Réunion
-
Saint-Benoît、La Réunion、法国、97470
- Groupe Hospitalier Est Réunion
-
Saint-Denis、La Réunion、法国、97400
- CHU de la Réunion
-
Saint-Paul、La Réunion、法国、97460
- Centre Hospitalier Gabriel Martin
-
Saint-Pierre、La Réunion、法国、97448
- CHU de la Réunion
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
|
Dislocation reduction using propofol
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recall incidence
大体时间:At 2 hours (+/- 15 minutes) after procedural sedation with propofol
|
questionnaire of Brice amended by Sandin
|
At 2 hours (+/- 15 minutes) after procedural sedation with propofol
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recall incidence
大体时间:About 24 hours after procedural sedation with propofol
|
The patient will be contacted by phone the next day after procedural sedation with propofol.
They will answer the questionnaire of Brice amended by Sandin
|
About 24 hours after procedural sedation with propofol
|
|
Patient's satisfaction assessment
大体时间:At 2 hours (+/- 15 minutes) after procedural sedation with propofol
|
numerical verbal scale
|
At 2 hours (+/- 15 minutes) after procedural sedation with propofol
|
合作者和调查者
调查人员
- 首席研究员:Pierre-Jean Marianne, MD、CHU de la Réunion
- 首席研究员:Marc Weber, MD、Groupe Hospitalier Est Réunion
- 首席研究员:Katia Mougin, MD、Centre Hospitalier Gabriel Martin
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 2013/CHU/08
- 2013-003669-32 (其他标识符:Agence National de Sécurité du Médicament)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.