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临床试验/NCT02775318
NCT02775318已完成1 期

Efficacy Of Ultrasound Guided Stellate Ganglion Block To Relieve Vasospasm Following Clipping Of Cerebral Aneurysm

Post Graduate Institute of Medical Education and Research, Chandigarh0 个研究点目标入组 20 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
20
主要终点
Presence or absence of aphasia before and after stellate ganglion block

研究概览

简要总结

The present study has been designed to assess the efficacy and safety of Stellate Ganglion Block (SGB) in relieving symptomatic cerebral vasospasm following aneurysmal clipping. The effect was assessed by both Digital Subtraction Angiography(DSA) and Transcranial Doppler (TCD).

详细描述

Anesthesiologist was informed about the patients (Post clipping for cerebral aneurysm) having neurological deterioration (hemiparesis, aphasia, apraxia, hemianopia, or neglect), or a decrease of ≥ 2 points on the Glasgow Coma Scale(GCS) and in whom the duration of symptoms lasted for at least 1 hour. Anesthesiologist was also informed if increased cerebral blood flow velocity was found on routine daily Transcranial Doppler(TCD) evaluation of such patients. A cerebral Computed tomography(CT) scan was performed at this time to rule out ventricular dilation or any other focal brain lesion explaining the clinical symptoms. In such patient Central venous pressure(CVP) was maintained at 8-10 mm of Hg and systolic blood pressure was maintained between 160-200 mm Hg (using infusion of vasopressors such as phenylephrine or dopamine if required). Oral/ nasogastric nimodipine (60 mg 4 hourly) was continued and hemoglobin was maintained at ≥ 10 gm/dl.

Diagnosis Of Vasospasm By Transcranial Doppler A 2 megahertz (MHz) transcranial Doppler ultrasound probe was used to insonate vessels through the temporal acoustic window. Extracranial Internal Carotid Artery (ICA) was insonated in the neck using a linear probe of 8- 13 MHz. Using Transcranial Doppler (TCD) probe, a tracing of waveform of Middle Cerebral Artery (MCA) was identified and confirmed using standard criteria. Peak Systolic Velocity and Mean Flow Velocity were assessed. Pulsatility Index and Resistivity Index were assessed. LINDEGAARD ratio was calculated.

Diagnosis Of Vasospasm By Digital Subtraction Angiography (DSA) Patients were shifted to Digital subtraction Angiography room and an emergency cerebral angiographic study was performed using Philips Allura Xper FD20/10 machine. Vasospasm was diagnosed on DSA and the vessel diameter was measured at the mid A1 segment of Anterior cerebral artery(ACA) and mid M1 segment of Middle Cerebral Artery (MCA). Vasospasm was classified as mild (<25%), moderate (25% to 50%), or severe (>50%) with respect to two - dimensional diameter at the mid A1 and mid M1 segment of ACA and MCA respectively. Location of vasospasm was classified as unilateral vs bilateral, single vessel involvement vs multiple vessel involvement or diffuse vasospasm (bilateral with multiple vessel involvement). Parenchymal filling time was calculated as the time delay between initiation of contrast injection till the appearance of parenchymal blush. Venous sinus filling time was calculated as the time delay between the initiation of contrast injection till the appearance of superior sagittal sinus. After diagnosis of vasospasm patients were administered ultrasound guided Stellate Ganglion block using 10 ml of 0.5% Injection Bupivacaine on the same side of vasospasm or the side contralateral to the focal neurological deficit.

Ultrasound Guided Stellate Ganglion Block - Technique Patients were kept supine with the neck in slight hyperextension. Under aseptic conditions, transducer is placed on the surface of the neck at the level of Cervical (C6) vertebrae. The internal jugular vein, carotid artery, thyroid gland, trachea, C6 vertebrae, transverse process of C6, esophagus, longus colli with its covering prevertebral fascia and esophagus are visualized. The transducer was pressed between the trachea and the carotid artery to retract the artery laterally as well as to position the transducer near the longus colli. A 25-gauge Quincke spinal needle was inserted paratracheal towards the middle of the longus colli muscle. The endpoint of the injection was the ultrasound image of the tip of the needle as it penetrates the prevertebral fascia covering the longus colli muscle. The drug is then injected and spread of drug is visualized as distension of prevertebral fascia around the longus colli muscle in real time.

Post Block Assessment-

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Any patient with post aneurysm clipping having symptomatic vasospasm i:e new onset of focal neurological impairment such as hemiparesis, aphasia, apraxia, hemianopia, or neglect or decrease of at least 2 points on the Glasgow Coma Scale (GCS) and duration of symptoms lasting for at least 1 hour.
  • Transcranial doppler confirmation of vasospasm by measuring cerebral blood flow velocity in MCA and LINDEGAARD ratio.
  • Cerebral angiographic confirmation of the presence of vasospasm by Digital subtraction angiography

排除标准

  • New onset of focal neurological deficit or deterioration in the level of consciousness due to other causes like re-bleeding, hydrocephalus, cerebral edema, electrolyte disorder, infection and seizure.
  • Patients having an infarct on cerebral tomography.
  • Patients with clipping of more than one aneurysm.
  • Patients with bilateral neurological deficits.
  • History of allergy to local anaesthetic agents.
  • Refusal of consent.
  • Deranged coagulation profile.
  • Patients with pre-existing pupillary changes where assessment of effectiveness of Stellate ganglion block will be difficult.
  • History of allergy to contrast media.
  • Derangement of renal parameters

研究组 & 干预措施

Stellate Ganglion Block

Other

After diagnosis of vasospasm patients were administered ultrasound guided Stellate Ganglion block using 10 cc of 0.5% Inj Bupivacaine on the same side of vasospasm or the side contralateral to the focal neurological deficit.Patients were then assessed using transcranial Doppler and digital subtraction angiography after 30 minutes

干预措施: Stellate Ganglion Block (Procedure)

Stellate Ganglion Block

Other

After diagnosis of vasospasm patients were administered ultrasound guided Stellate Ganglion block using 10 cc of 0.5% Inj Bupivacaine on the same side of vasospasm or the side contralateral to the focal neurological deficit.Patients were then assessed using transcranial Doppler and digital subtraction angiography after 30 minutes

干预措施: Bupivacaine (Drug)

Stellate Ganglion Block

Other

After diagnosis of vasospasm patients were administered ultrasound guided Stellate Ganglion block using 10 cc of 0.5% Inj Bupivacaine on the same side of vasospasm or the side contralateral to the focal neurological deficit.Patients were then assessed using transcranial Doppler and digital subtraction angiography after 30 minutes

干预措施: Transcranial Doppler (Procedure)

Stellate Ganglion Block

Other

After diagnosis of vasospasm patients were administered ultrasound guided Stellate Ganglion block using 10 cc of 0.5% Inj Bupivacaine on the same side of vasospasm or the side contralateral to the focal neurological deficit.Patients were then assessed using transcranial Doppler and digital subtraction angiography after 30 minutes

干预措施: Digital Subtraction Angiography (Procedure)

结局指标

主要结局

Presence or absence of aphasia before and after stellate ganglion block

时间窗: it will be assessed at baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after stellate ganglion block

Change in Glasgow Coma Scale from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

时间窗: change in Glasgow Coma Scale from baseline will be assessed a 30 minutes,1 hour, 6,12, 24, 36, 48 hours

Change in motor power on motor system examination from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

时间窗: change in motor power on motor system examination from baseline will be assessed a 30 minutes,1 hour, 6,12, 24, 36, 48 hours

次要结局

  • Change in Pulsatility Index on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients(Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block)
  • Change in parenchymal filling time on Digital Subtraction Angiography from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients(Parameters will be assessed at Baseline and 30 minutes)
  • Change in Mean Flow Velocity on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients(Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block)
  • Change in LINDEGAARD ratio on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients(Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block)
  • Change in Peak systolic velocity on Transcranial doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients(Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block)
  • Change in vessel calibre on Digital Subtraction Angiography from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients(Parameters will be assessed at Baseline and 30 minutes)
  • Change in Venous sinus filling time on Digital Subtraction Angiography from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients(Parameters will be assessed at Baseline and 30 minutes)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

NAVNEH SAMAGH

Senior Resident In Neuroanesthesia,Department of Anesthesia and Intensive Care

Post Graduate Institute of Medical Education and Research, Chandigarh

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