NCT04350086撤回4 期
Prospective Study of the Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection
University Hospital, Limoges1 个研究点 分布在 1 个国家开始时间: 2020年4月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine.
研究概览
简要总结
The current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations.
Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics.
The hypothesis of this study is that Dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from Covid-19 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Major patient
- •Relating to palliative care
- •With sars-cov-2 infection
- •Requiring light to moderate sedation corresponding to a RASS score of -1 to -3
排除标准
- •Pregnant, lactating woman.
- •Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the summary of product characteristics
- •Advanced heart block (level 2 or 3) unless a pacemaker.
- •Uncontrolled hypotension.
- •Acute cerebrovascular pathologies.
- •Use of other sedative drugs
研究组 & 干预措施
Experimental arm
Experimental
干预措施: Treatment with Dexmedetomidine (Drug)
结局指标
主要结局
Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine.
时间窗: Day 30
Number of days of mild to moderate sedation induced by dexmedetomidine until death or change of molecule.
次要结局
- Daily analgesic effect of Dexmedetomidine(Day 30)
- Other sedative pharmacological agents(Day 30)
- Average dosage required for Dexmedetomidine to achieve mild to moderate sedation(Day 30)
- Overall survival of patients on Dexmedetomidine(Day 30)
研究者
研究点 (1)
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