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Stellate Ganglion Block Using Ultrasound Guidance For Treatment Of Post Clipping Cerebral Vasospasm

Primary Purpose

Cerebral Vasospasm

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Stellate Ganglion Block
Bupivacaine
Transcranial Doppler
Digital Subtraction Angiography
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Vasospasm focused on measuring Stellate Ganglion, Digital Subtraction Angiography, Transcranial Doppler Ultrasonography

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Stellate Ganglion Block

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    Change in Glasgow Coma Scale from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    Change in motor power on motor system examination from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    Presence or absence of aphasia before and after stellate ganglion block

    Secondary Outcome Measures

    Change in Peak systolic velocity on Transcranial doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    Change in Mean Flow Velocity on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    Change in LINDEGAARD ratio on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    Change in Pulsatility Index on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    Change in vessel calibre on Digital Subtraction Angiography from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    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
    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

    Full Information

    First Posted
    May 9, 2016
    Last Updated
    May 12, 2016
    Sponsor
    Postgraduate Institute of Medical Education and Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02775318
    Brief Title
    Stellate Ganglion Block Using Ultrasound Guidance For Treatment Of Post Clipping Cerebral Vasospasm
    Official Title
    Efficacy Of Ultrasound Guided Stellate Ganglion Block To Relieve Vasospasm Following Clipping Of Cerebral Aneurysm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Postgraduate Institute of Medical Education and Research

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    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- • Development of ipsilateral Horner Syndrome at 5 minutes interval till 30 minutes after block to confirm successful Stellate Ganglion Block. At thirty minutes after the block the following parameters are assessed:- Neurological condition (GCS score, motor deficits, aphasia, apraxia, hemianopia or neglect). Assessment was done by a blinded neurosurgeon. Hemodynamic parameters: heart rate, blood pressure Transcranial doppler measurement of flow velocity in MCA, Pulsatility index(PI), Resistivity Index(RI) and LINDEGAARD ratio. Digital subtraction angiography was repeated to measure diameter of the vessels affected by vasospasm, change in grading of vasospasm, any increase in vessel diameter, parenchymal filling time and venous sinus filling time. Any increase or decrease in parenchymal and venous sinus filling time was noted. Block Failure- Block was considered a failure if no signs of Horner's syndrome appeared after 30 minutes of SGB block. Ineffective Stellate ganglion block- Block was considered ineffective after 30 minutes of Stellate ganglion block If there was no neurological improvement No improvement in Transcranial doppler findings to normal level or no significant change in affected vessel diameter, grading of vasospasm, parenchymal filling time and venous sinus filling time in second Digital subtraction angiography Rescue Management In case of ineffective block, patients were given intra-arterial nimodipine at rate of 0.1 milligram / minute for a maximum dose of 3 milligram /artery as a rescue measure. Following this improvement, these patients were monitored in Intensive care unit(ICU). Management Of Patient In Intensive Care Unit Avoidance of hypotension. Maintenance of Systolic Blood Pressure(SBP) at 160-200 mm of Hg using vasopressor {(phenylephrine 2-17microgram/Kg/min) and/or (dopamine-5-10 microgram/kg/min)} Avoidance of hypovolemia, maintain Central venous pressure at 8-10 mm of Hg Maintenance of Hemoglobin ≥ 9gram/decilitre Oral/nasogastric Nimodipine 60mg 4 hourly. Clinical course of patients was followed. Baseline neurological, hemodynamic and TCD parameters were reassessed by the anesthesiologist at 30 minutes . Patients with effective block were reassessed for neurological status and flow velocity measurements by Transcranial Doppler at 6 hours, 12 hours, 24 hours, 36 hours and 48 hours after Stellate ganglion block. Patients with ineffective block who received rescue management were not reassessed for neurological status and flow velocity measurements using Transcranial Doppler at various intervals by the anesthesiologist. However the complications occurring in them, the duration of their stay in the hospital and the final outcome in the form of discharge or death was noted. Complications Of Stellate ganglion block Procedure and drug-related complications were noted. Complications During Hospital Stay Complications occurring in the post Stellate Ganglion Block period during the entire hospital stay other than those due to the stellate ganglion block per se were noted. Duration of hospital stay was also noted.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Vasospasm
    Keywords
    Stellate Ganglion, Digital Subtraction Angiography, Transcranial Doppler Ultrasonography

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stellate Ganglion Block
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Stellate Ganglion Block
    Intervention Description
    Under aseptic conditions, transducer is placed on the surface of the neck at the level of 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. 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 in real time.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Other Intervention Name(s)
    Sensorcaine, Marcaine
    Intervention Description
    10 ml of 0.5% injection bupivacaine is used for giving stellate ganglion block on the side of cerebral vasospasm
    Intervention Type
    Procedure
    Intervention Name(s)
    Transcranial Doppler
    Intervention Description
    The principle on which the TCD works is that with arterial narrowing, the blood flow velocity within the vessel increases. A good correlation has been found between the TCD blood flow velocities and vasospasm. The MCA velocity greater than 120 cm/sec indicates mild vasospasm , velocity greater than 130 cm/sec indicates moderate vasospasm and velocity greater than 200 cm/sec indicates severe vasospasm.
    Intervention Type
    Procedure
    Intervention Name(s)
    Digital Subtraction Angiography
    Other Intervention Name(s)
    DSA
    Intervention Description
    Digital subtraction angiography is a direct method for the assessment of vessel caliber. It generates high resolution, high contrast and low artifact images using digital subtraction technology. Direct visualization using DSA is the gold standard for the radiographic diagnosis of cerebral vasospasm
    Primary Outcome Measure Information:
    Title
    Change in Glasgow Coma Scale from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    Time Frame
    change in Glasgow Coma Scale from baseline will be assessed a 30 minutes,1 hour, 6,12, 24, 36, 48 hours
    Title
    Change in motor power on motor system examination from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    Time Frame
    change in motor power on motor system examination from baseline will be assessed a 30 minutes,1 hour, 6,12, 24, 36, 48 hours
    Title
    Presence or absence of aphasia before and after stellate ganglion block
    Time Frame
    it will be assessed at baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after stellate ganglion block
    Secondary Outcome Measure Information:
    Title
    Change in Peak systolic velocity on Transcranial doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    Time Frame
    Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block
    Title
    Change in Mean Flow Velocity on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    Time Frame
    Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block
    Title
    Change in LINDEGAARD ratio on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    Time Frame
    Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block
    Title
    Change in Pulsatility Index on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    Time Frame
    Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block
    Title
    Change in vessel calibre on Digital Subtraction Angiography from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients
    Time Frame
    Parameters will be assessed at Baseline and 30 minutes
    Title
    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
    Time Frame
    Parameters will be assessed at Baseline and 30 minutes
    Title
    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
    Time Frame
    Parameters will be assessed at Baseline and 30 minutes

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Stellate Ganglion Block Using Ultrasound Guidance For Treatment Of Post Clipping Cerebral Vasospasm

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