A Randomized, Open Label, Multicentre Study to Compare the Pharmaco-economic Implications of an Analgesia Based Regimen With Remifentanil and a Conventional Sedation Based Regimen Using Propofol in Medical and Post-surgical ICU Subjects Requiring Mechanical Ventilation for at Least 2 Days.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Duration of Time on Mechanical Ventilation (Per-Protocol Population)
研究概览
简要总结
This study will be a multicentre randomized, open-label, phase IIIb study. This study will evaluate two different techniques of sedation: an analgesia based regimen with remifentanil versus a conventional sedation based regimen using propofol in subjects that require mechanical ventilation for at least 2 days in the ICU. The conventional sedation based regimen will consist of propofol combined with an opioid according to routine clinical practice (morphine, fentanyl, sufentanil or other as required) . The analgesia based regimen will consist of remifentanil, with propofol added on if required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Medical and post-surgical patients admitted to ICU and requiring mechanical ventilation.
- •Intubated subjects expected to require mechanical ventilation for longer than 48 hours after starting the study drug.
- •Subjects requiring both analgesia and sedation with a regimen comprising a hypnotic agent and an opioid.
排除标准
- •Diagnosis: cardiopulmonary resuscitation (CPR) in the previous 24 hours or expecting to require major surgery within the next three days
- •Subject who, in the judgement of the investigator, has a life expectancy of 2 days or refrained or refuses full life support, which would limit the care provided
- •Concurrent medications:
- •Requires or is likely to require neuromuscular blocking agents by continuous infusion to facilitate mechanical ventilation
- •Has or is likely to receive an epidural block during the treatment period
研究组 & 干预措施
Remifentanil
remifentanil
干预措施: Remifentanil (Drug)
Propofol
Propofol infusion
干预措施: Propofol (Drug)
结局指标
主要结局
Duration of Time on Mechanical Ventilation (Per-Protocol Population)
时间窗: Up to 38 days (912 hours)
Time from start of mechanical ventilation until actual extubation
Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)
时间窗: Up to 38 days (912 hours)
Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).
Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)
时间窗: Up to 38 days (912 hours)
Time from start of mechanical ventilation until actual extubation.
次要结局
- Duration of Extubation(up to 38 days (912 hours))
- Duration of Time in Intensive Care Unit (ICU) and Potential Stay in ICU (the Time Expected for Extubation, i.e., the Time Between Intubation and Eligibility for Extubation, According to Investigator's Decision)(Up to 38 days (912 hours))
- Duration of Weaning(up to 38 days (912 hours))
- Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)(up to 10 days (240 hours))
- Dose of Remifentanil Administered - Continuous Infusion(Up to 10 days)
- Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale(Up to 38 Days)
- Doses of Sufentanil and Fentanil Administered - Continuous Infusion(up to 10 days)
- Duration of Remifentanil Infusion (ITT Population)(Up to 10 days (240 hours))
- Duration of Propofol Infusion (ITT Population)(up to 10 days (240 hours))
- Dose of Morphine Administered - Continuous Infusion(up to 10 days)
- Total Dose of Propofol Administered - Bolus(Up to 10 days)
- Dose of Propofol Administered - Continuous Infusion(Up to 10 days)
- Total Dose of Fentanil Administered - Bolus(Up to 10 days)
- Sedation-Agitation for Day 7(Day 7)
- Sedation-Agitation From Day 8 to Day 10(Days 8, 9, and 10)
- Number of Participants Analyzed for BIS (Bispectral Index Scale)(Up to 38 days)
- Bispectral Index (BIS)(Screening through End of Study, up to 38 days)
- Bispectral Index (BIS) for Day 5(Day 5)
- Sedation-Agitation From Screening Through the End of Study(Up to 38 days)
- Bispectral Index (BIS) for Extubation Period and Post-Extubation Period(up to 38 days)
- Pain Intensity (PI)(Up to 38 days)
- Pain Intensity From Day 8 to Day 10(Days 8, 9, and 10)