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Cerebral VasospasmPhase 1NCT02775318

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

A Phase 1 study testing Stellate Ganglion Block, Bupivacaine and Transcranial Doppler in people with Cerebral Vasospasm, run by Post Graduate Institute of Medical Education and Research, Chandigarh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Cerebral Vasospasm
What is being tested?
Stellate Ganglion Block, Bupivacaine and Transcranial Doppler
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Sep 2014to Jul 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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

About this study

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

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).

Read the 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.

Being tested
Stellate Ganglion Block, Bupivacaine, Transcranial Doppler, Digital Subtraction Angiography
Keywords
Stellate Ganglion, Digital Subtraction Angiography, Transcranial Doppler Ultrasonography
Medical subject headings
Vasospasm, Intracranial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stellate Ganglion BlockProcedure or surgery

    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.

  • BupivacaineDrug

    Also called Sensorcaine, Marcaine

    10 ml of 0.5% injection bupivacaine is used for giving stellate ganglion block on the side of cerebral vasospasm

  • Transcranial DopplerProcedure or surgery

    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.

  • Digital Subtraction AngiographyProcedure or surgery

    Also called DSA

    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

Study groups in NCT02775318
Study groupRoleWhat they receive
Stellate Ganglion BlockOtherAfter 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
Receives: Procedure: Stellate Ganglion Block; Drug: Bupivacaine; Procedure: Transcranial Doppler; Procedure: Digital Subtraction Angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

  3. Presence or absence of aphasia before and after stellate ganglion block

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

Secondary outcomes (7)
  1. Change in Peak systolic velocity on Transcranial doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

    Measured: Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block

  2. Change in Mean Flow Velocity on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

    Measured: Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block

  3. Change in LINDEGAARD ratio on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

    Measured: Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block

  4. Change in Pulsatility Index on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

    Measured: Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block

  5. Change in vessel calibre on Digital Subtraction Angiography from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

    Measured: Parameters will be assessed at Baseline and 30 minutes

  6. 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

    Measured: Parameters will be assessed at Baseline and 30 minutes

  7. 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

    Measured: Parameters will be assessed at Baseline and 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2016 (estimated)
  2. Study startSep 2014
  3. Primary completionApr 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02775318
Sponsor's protocol ID
NK/1286/DM/1060
Status last verified
May 2016
First submitted
9 May 2016
Last updated
17 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Stellate Ganglion Block, Bupivacaine and Transcranial Doppler in people with Cerebral Vasospasm, run by Post Graduate Institute of Medical Education and Research, Chandigarh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.

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