Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy of Oral Nimodipine and Intravenous Milrinone: Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Concentration of transcutaneous cerebral mixed oxygen saturation
研究概览
简要总结
To evaluate the efficacy and safety of oral Nimodipine and IV milrinone combination therapy for management of cerebral spasm after aneurysmal subarachnoid hemorrhage.
详细描述
after being informed about the study and potential risks. All patients giving written consent will be randomized by double-blind manner into 2groups each one containing 15 patients.
Group 1(n =15 ):the patients will receive nimodipine (60 mg/4 hours) orally or via nasogastric tube In group 2(n =15 ): the patients will receive Oral Nimodipine (60 mg/4) will be given orally or in the gastric tube also from the first day of admission, then after the diagnosis of vasospasm is confirmed, start milrinone.
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
- Double (Participant, Investigator)
盲法说明
double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients admitted to our surgical ICU
- •aged between (18-60) years old
- •World Federation of Neurological Surgeons grades 1-3 Grades
排除标准
- •Aneurysmal SAH
- •SAH with Fisher Grade I and IV,
- •World Federation of Neurological Surgeons grade IV & V
- •No informed consent,
- •peripheral vascular disease
- •Cardiac disease (heart block, severe valvular stenosis, cardiomyopathothy , ejection fraction<40%), Renal impairment (serum creatinine ≥ 1.4 mg.L-1), Hemodynamic instability
研究组 & 干预措施
triple H group
The patients will receive nimodipine (60 mg/4 hours) orally or via nasogastric tube from the first day of admission, then after the diagnosis of vasospasm is confirmed, Triple H therapy (hypertension, hypervolemia and hemodilution) will be started. norepnnephrine (0.01-0.2ug/kg/min) to mentain main arterial blood pressure >100mmhg and hypervolemia to maintain the CVP around 12---14 mmHg and hemodilution to maintain the haematocrit between 30% and 33%.
干预措施: nimodipine (Drug)
Milrinone group
The patients will receive oral Nimodipine (60 mg/4) will be given orally or in the gastric tube also from the first day of admission, then after the diagnosis of vasospasm is confirmed, start milrinone bolus of 0.1-0.2 mg/kg followed by 0.75mcg/k/min, if no response after 30min increase the infusion to 1-25mcg/kg/min with maintaining CVP 5:8.
Norepinephrine (0.01-0.2ug/kg/min) is used only to restore the mean arterial pressure (MAP) to its previous values If there was no recurrence of symptoms after 72 h, we decreased the milrinone infusion by 0.25 mcg/kg/min every 24 or 48 h until discontinuation. If there are any recurrent of symptoms of vasospasm, the patients are placed back on the dose they were previously receiving. If required, another Milrinone bolus is administered if the patient's deficits do not revert12.
干预措施: Oral Nimodipine and milrinone (Drug)
结局指标
主要结局
Concentration of transcutaneous cerebral mixed oxygen saturation
时间窗: every 24 hours up to 1 week
by forehead bilateral interconnected adhesive probes
次要结局
- Number of participants restore of the previous conscious level and motor state(Percentage of drug success)(1 hour after administration of milrinone and 2 hours after administration of triple H therapy)
- value of Modified Rankin scale(3,6,12 monthes after drug administration)
- Number of participants develop one of adverse events(after administration of the study drugs up to 30 days)
- Total ICU and hospital stay(up to 30 days after administration of the study drugs)
- mortality rate(30 day after administration of the study drugs)
- Glasgow Outcome Scale(3,6,12 monthes after drug administration)
- value of Glasgow coma scale(every 24 hours up to total days of ICU and hospital stay)
- Number of participants having cerebral infarction (cerebral infarction incidence)(every 48 hours up to 1 week)
研究者
Marwa Mohamed Medhat
lecture of anesthesia and surgical intensive care (Principal Investigator)
Zagazig University