Morphine, Midazolam and Dexmedetomidine in the Management of Acute Cardiogenic Pulmonary Edema, Safety and Efficacy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Clinical improvement in length of hospital stay
研究概览
简要总结
Acute cardiogenic pulmonary edema is a stressful scenario with progressive respiratory failure that may lead to cardiorespiratory collapse within hours, or minutes unless therapeutic action is taken As the initial events in involve hemodynamic pulmonary congestion with high capillary pressures, diuretics, non-invasive ventilation (NIV) and vasodilators constitute the key armamentarium for the initial treatment.
详细描述
The patients will be randomized in a 1:1:1 ratio, (group midazolam i) midazolam (administered intravenously at a dosage of 1 mg, up to a maximum dose of 3 mg) (group morphine) morphine (administered intravenously at a dosage of 2-4 mg, up to a maximum dose of 8 mg [14], [15],(group Dexmedetomidine.) dexmedetomidine ( administered intravenously, Load: 0.25 mcg/kg IV over 10 minutes , Maintenance 0.2-0.7 mcg/kg/hr continuous IV infusion according to haemodynamics and sedation score of patient ; not to exceed 24 hr
• Boluses of morphine, midazolam and dexmeddetomidine will be repeated on demand according to Ramsay sedation scale.
• All patients will be assessed for need of noninvasive ventilation by total face mask connected to ventilator.
• Medical therapy with intravenous boluses of loop diuretics, intravenous infusions of nitroglycerine, oxygen supplementation will be provided by physicians according to their clinical judgment
• The target in all patients is to provide anxiolytic or light sedation effect for good compliance to noninvasive ventilation and reducing of pulmonary congestion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 year with a clinical diagnosis of ACPE with severe dyspnea and anxiety.
- •Patients able to verbally acknowledge the risks in receiving midazolam, morphine or dexmedetomidine.-
- •Diagnosis of ACPE was defined by the association of sudden onset of dyspnoea, the presence of bilateral rales on auscultation, respiratory rate >25 breaths/min and pulse oxygen saturation <90% in room air. diagnosis will be confirmed by echocardiography and lung ultrasound
排除标准
- •Patients with history of asthma, severe stenotic valvular disease. • Cardiovascular collapse or an impaired level of consciousness (Glasgow Coma Scale score of ≤8 points).
- •Immediate indication for intubation.
- •Suspicion of ST-segment elevation, acute coronary syndrome needing interventions.
- •Known severe liver or renal disease, pneumonia, poor chance of survival due to a pre-existing condition.
- •Psychiatric disorders.
研究组 & 干预措施
group Midazolam
midazolam (administered intravenously at a dosage of 1 mg, up to a maximum dose of 3 mg) on demand
干预措施: Injection (Drug)
GROUP Morphine
morphine (administered intravenously at a dosage of 2-4 mg, up to a maximum dose of 8 mg every 12 hours
干预措施: Injection (Drug)
Group Dexmedetomidine
dexmedetomidine ( administered intravenously, Load: 0.25 mcg/kg IV over 10 minutes , Maintenance 0.2-0.7 mcg/kg/hr continuous IV 7 infusion according to haemodynamics and sedation score of patient ; not to exceed 24 hr
干预措施: Injection (Drug)
结局指标
主要结局
Clinical improvement in length of hospital stay
时间窗: 48 hours
次要结局
- In- hospital all- cause mortality.(72 hours)
- mortality(30-day)
研究者
Amany Said Abdel Haleem
Lecturer of Anesthesia and Intensive care
Menoufia University