Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance After Cardiac Surgery: a Multicenter, Prospective, Single-blind, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Remission rate of intolerance in patients with intolerance of non-invasive mechanical ventilation after cardiac surgery after sedation with remifentanil or dexmedetomidine.
研究概览
简要总结
Currently, NIV(Noninvasive ventilation ) is widely used in patients with hypoxemia and atelectasis after cardiac surgery.About 15% of patients have intolerance during NIV. The main manifestation is that the patient feels uncomfortable, often breaks away from the mask, and even gradually becomes agitated, which eventually leads to the failure of non-invasive ventilation.The patient's intubation rate is as high as 44%, and the mortality rate is 34%.There are many ways to prevent or treat NIV intolerance, of which the most used is to sedate the patient. This study aims to evaluate the effects of remifentanil and dexmedetomidine in the sedation of patients with intolerance to non-invasive mechanical ventilation after cardiac surgery, and to explore the optimal plan for sedation of patients with intolerant non-invasive mechanical ventilation after cardiac surgery.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form voluntarily and follow the plan requirements;
- •Age from 18 to 75 years old (including 18 and 75 years old), regardless of gender;
- •Patients who received non-invasive mechanical ventilation after cardiac surgery and were intolerant of non-invasive ventilation.
排除标准
- •A history of allergy to any component of the study drug;
- •Visual analogue scale of pain (VAS) score >4；
- •Who had taken dexmedetomidine within 8 hours prior to the study;
- •Who had used remifentanil within 2 hours before the study began;
- •Expectoration difficulties;
- •Women who are pregnant or lactating;
- •Coma or uncontrollable convulsions;
- •Have a history of mental illness or cognitive impairment;
- •Delirium before the study began;
- •Patients with severe liver dysfunction (CTP grade C);
- •Patients with renal insufficiency (patients receiving renal replacement therapy);
- •Preoperative left ventricular ejection fraction (LVEF) < 30%;
- •History of drug and alcohol abuse;
- •Other conditions that the investigator deems inappropriate for participation in this clinical trial.
研究组 & 干预措施
Remifentanil group
干预措施: Remifentanil (Drug)
Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Remission rate of intolerance in patients with intolerance of non-invasive mechanical ventilation after cardiac surgery after sedation with remifentanil or dexmedetomidine.
时间窗: Within 72 hours of study drug used
次要结局
- Days in ICU in both remifentanil and dexmedetomidine group(Up to 30 days)
- Incidence of delirium in both remifentanil and dexmedetomidine group(Up to 30 days)
- Mortality in both remifentanil and dexmedetomidine group(Up to 30 days)
- Mechanical ventilation time in both remifentanil and dexmedetomidine group(Up to 30 days)
- Hemodynamic changes in both remifentanil and dexmedetomidine group(Up to 30 days)
- Intubation rate in both remifentanil and dexmedetomidine group(Up to 30 days)
- Tracheotomy rate in both remifentanil and dexmedetomidine group(Up to 30 days)
研究者
Guowei Tu
Associated professor
Shanghai Zhongshan Hospital