NCT02548923已完成4 期
Dexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients
University of Tennessee Graduate School of Medicine1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Duration of Mechanical Ventilation
研究概览
简要总结
The purpose of this study is to assess the efficacy of dexmedetomidine versus propofol for prolonged sedation in trauma and surgical patients.
详细描述
Design: Open-label, single-center prospective study. Setting: Trauma/Surgical Intensive Care Unit (TSICU) at a Level I academic trauma center.
Patients: Patients 18 years of age or older requiring mechanical ventilation and admitted to the TSICU Interventions: Patients were randomly assigned based on unit bed location to receive dexmedetomidine or propofol for sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Patients were included in the study if they were 18 years of age or older,
- •mechanically ventilated,
- •placed on the institutional sedation protocol,
- •expected to require sedation lasting 24 hours after randomization, and
- •admitted to the TSICU and followed by the Trauma/Surgical Service.
排除标准
- •Patients were excluded for any of the following:
- •72 hours or greater since sedation protocol initiation,
- •treatment per the institutional traumatic brain injury (TBI) protocol,
- •concomitant continuous infusion of a neuromuscular blocking agent,
- •heart rate less than 50 beats per minute,
- •mean arterial pressure less than 55 mmHg despite fluid resuscitation and vasopressors, and
- •use of other alpha-2 agonists within 24 hours of randomization.
研究组 & 干预措施
dexmedetomidine group
Active Comparator
Patients who received dexmedetomidine for sedation
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Duration of Mechanical Ventilation
时间窗: ICU stay
An average of 10 days
次要结局
- Mortality(Hospital length of stay)
- proportion of time in target sedation(ICU length of stay)
- incidence of delirium(ICU length of stay)
- hypotension(ICU length of stay)
- bradycardia(ICU length of stay)
- ICU and hospital length of stay(hospital length of stay)
研究者
Brian Daley
Professor
University of Tennessee Graduate School of Medicine
研究点 (1)
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