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临床试验/CTRI/2019/04/018516
CTRI/2019/04/018516尚未招募不适用

Effect of stellate ganglion block on cardiac rhythm in patients with acute aneurysmal sub-arachnoid hemorrhage with vasospasm: a holter-based preliminary study.

All India Institute of Medical Sciences New Delhi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
effects of stellate ganglion block (SGB) used for treatment of cerebral vasospasm following acute aneurysmal subarachnoid haemorrhage (aSAH) on cardiac rhythm with Holter monitoring.

研究概览

简要总结

Use of SGB been reported for the managementof cerebral vasospasm following aneurysmal subarachnoid hemorrhage (aSAH).Treggiari andcolleagues (2003) suggested use of superior cervical sympathetic block torelieve cerebral vasospasm in patients with subarachnoid hemorrhage (SAH) anddemonstrated improved cerebral perfusion without change in vessel diameter atcerebral angiography. Subarachnoid hemorrhage (SAH) has long been known tobe associated with abnormalities of ‘R’ and ‘T’ waves, S-T segment changes andpresence of ‘U’ waves in the electrocardiogram.In addition,cardiac rhythm abnormalities in the form of sinus bradycardia and sinustachycardia, wandering atrial pacemaker and atrial fibrillation are alsocommonly encountered after aneurysmal SAH. Di Pasquale and co-researchers (1987) performed holter monitoring insubarachnoid hemorrhage patients up to about 72 hours after ictus and reported arrhythmias in96 (90%) of the 107 patients.However, a recent study reported that about 8%patients with SAH had an arrhythmia sometime during their hospital stay. Half of these arrhythmias were clinically significantand developed a median of 3 days after ictus. Efforts have been made to study effects of modulatingsympathetic supply to the heart through stellate ganglion block, though not in patients suffering fromaSAH, but theresults are not clear. Malik and associates (2014) reported percutaneous inferiorcervical sympathetic ganglion blockade effective  for the treatment of ventricular tachycardiastorm.Efforts have been made to study effects of modulatingsympathetic supply to the heart through stellate ganglion block, though not in patients suffering fromaSAH, but theresults are not clear.Malik and associates (2014) reported percutaneous inferiorcervical sympathetic ganglion blockade effective  for the treatment of ventricular tachycardiastorm. Chen andcolleagues (2015), reported protective effect of SGB on the myocardium andsuppression of stress responses during anesthetic induction and trachealintubation.We hypothesizethat SGB can reduce incidence of cardiac arrythmias in patients with aSAH.

At the All India Institute of Medical Sciences, about150 patients are admitted with aneurysmal subarachnoid hemorrhage (aSAH) annually andtwo thirds of these undergo surgical clipping. During the postoperative course, in several of thesepatients stellate ganglion block is performed for the management of symptomaticcerebral vasospasm.

Till date, effect of SGB on cardiac rhythm has notbeen studied in patients with aneurysmal SAH, therefore, we planned to prospectively studyeffect of SGB on cardiac rhythm with holter monitoring in patients suffering from cerebralvasospasm following acute aneurysmal SAH.

Primary objective

To study effects of stellate ganglion block (SGB) usedfor treatment of cerebral vasospasm following acute aneurysmal subarachnoidhemorrhage (aSAH) on cardiac rhythm with Holter monitoring.

Secondary objectives

ØTo studyhemodynamic parameters after stellate ganglion block (SGB) for treatment of cerebralvasospasm following acute aneurysmal subarachnoid hemorrhage (aSAH).

ØTo studyneurological outcome after treatment of cerebral vasospasm with stellate ganglionblock (SGB) following acute aneurysmal subarachnoid hemorrhage (aSAH).

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • patients aged 18-65 years belonging to either sex, requiring stellate ganglion block for treatment of clinical cerebral vasospasm after undergoing microsurgical clipping of cerebral aneurysm will be studied.

排除标准

  • Refusal of consent, patients with multiple aneurysms and having an unsecured aneurysm, history of allergy to local anaesthetics, disturbed coagulation profile and patient with preexisting pupillary changes where assessment of effectiveness of stellate ganglion block (SGB) would be difficult.

结局指标

主要结局

effects of stellate ganglion block (SGB) used for treatment of cerebral vasospasm following acute aneurysmal subarachnoid haemorrhage (aSAH) on cardiac rhythm with Holter monitoring.

时间窗: 24 hours after stellate ganglion block

次要结局

  • 1.To study hemodynamic parameters after stellate ganglion block (SGB) for treatment of cerebral vasospasm following acute aneurysmal subarachnoid haemorrhage (aSAH).(2.To study neurological outcome after treatment of cerebral vasospasm with stellate ganglion block (SGB) following acute aneurysmal subarachnoid haemorrhage (aSAH).)

研究者

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Government medical college

研究点 (1)

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