Sedation of Surgical Patients in the Intensive Care Unit: A Randomized Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Extubation time
研究概览
简要总结
The purpose of this study is to compare propofol-remifentanil sedation with midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in the ICU, as well as the incidence of delirium. Primary end-points were weaning time and extubation time, and secondary end-points were the incidence of delirium and length of stay in the ICU.
详细描述
With on-going emphasis on early extubation, as well as further recognition of morbidity and mortality associated with delirium, the specific sedatives and analgesics used in the ICU is an issue of interest. Recent studies have focused on comparing sedatives, but interpretations are often confounded by the fact that in most studies, different analgesics were used when comparing two sedative medications. The role of remifentanil as the main analgesic in the ICU is being recognized. Pharmacodynamic and pharmacokinetic profiles of remifentanil makes it an ideal analgesic in the ICU setting. The investigators therefore designed this randomized study to compare sedation with propofol and midazolam in a remifentanil-based sedation and analgesia.
The purpose of this study is to compare propofol-remifentanil sedation with midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in the ICU, as well as the incidence of delirium. Primary end-points were weaning time and extubation time, and secondary end-points were the incidence of delirium and length of stay in the ICU.
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
- •surgical patients over 18 years old who were admitted to the ICU for postoperative ventilator care after sevoflurane-remifentanil based general anesthesia
排除标准
- •pre-existing neurologic dysfunction (dementia)
- •head trauma patients
- •previous history of alcohol abuse or substance abuse
- •patients who had baseline serum creatinin levels of over 2.5mg/100ml
- •uncompensated liver cirrhosis
- •hemorrhagic, cardiogenic, or septic shock
- •pregnancy or breast feeding
- •tracheostomy or extubation before ICU admission.
研究组 & 干预措施
Propofol
干预措施: Propofol infusion (Drug)
Midazolam
干预措施: Midazolam infusion (Drug)
结局指标
主要结局
Extubation time
时间窗: monitored from dicontinuation of sedatives to extubation, during an expected average of 3 hours
the time to extubation : defined as the time from discontinuation of infusion to extubation
次要结局
- delirium(monitored during the entire ICU stay (an expected average of 6 days))
