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Cervical Sympathetic Block in Patients With Cerebral Vasospasm

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Stanford University

Status

Invitation-only

Conditions

Subarachnoid Hemorrhage, Aneurysmal
Anesthesia, Local
Cerebral Vasospasm

Treatments

Procedure: Cervical sympathetic block

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purposes of this study are twofold: 1) to assess the effect of a cervical sympathetic block on cerebral blood flow in patients suffering from cerebral vasospasm, after aneurysmal subarachnoid hemorrhage; 2) to evaluate the effect of the sympathetic block on the recovery of the neurological function.

Full description

Patients hospitalized in the intensive care unit (ICU) and developing clinical manifestations of cerebral vasospasm will be transferred to the neuro-interventional radiology suite for vasospasm treatment. After the vasospasm is confirmed by the angiography followed by a flat panel-computed tomography perfusion (FP-CTP) scan, a cervical sympathetic nerve block under ultrasound guidance will be performed.

The block consists of the deposition of local anesthetic at the cervical sympathetic ganglion that will be visualized with an ultrasound device. The local anesthetic solution with be mixed with a radiographic contrast agent to check the spread of the injectate in the desired anatomical location. The spread of the local anesthetic will be assessed by performing an 8-second head/neck C-arm CT scan. Following the block, another run of angiography and a second FP-CTP will be repeated to assess changes in vessels diameter and in perfusion parameters following the sympathetic block.

Patients will have a daily monitoring of their neurological function and of their cerebral blood flow with transcranial doppler in the ICU.

At 12 months post-aSAH, the patients will complete neurological and neuropsychological assessments as a part of the standard of care. The results of these tests will be collected for analysis.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ages 18 and over
  • patients hospitalized in the ICU and developing cerebral vasospasm after aneurysmal subarachnoid hemorrhage

Exclusion criteria

- known advanced stage kidney disease

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Cervical sympathetic block
Experimental group
Description:
Patients hospitalized in the ICU and developing clinical manifestations of cerebral vasospasm will be transferred to the neuro-interventional radiology suite for vasospasm treatment. After the vasospasm is confirmed by the angiography followed by a FP-CTP scan, a cervical sympathetic nerve block under ultrasound guidance will be performed. The block consists in the deposition of local anesthetic at the cervical sympathetic ganglion that will be visualized with an ultrasound device. The spread of the local anesthetic will be assessed by performing an 8-second head/neck C-arm CT scan. Another run of angiography and a second FP-CTP will be repeated to check the effect of the block on the brain vasculature after the block is done. Patients will have a daily monitoring of their neurological function and of their cerebral blood flow with transcranial doppler in the ICU.
Treatment:
Procedure: Cervical sympathetic block

Trial contacts and locations

1

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Central trial contact

Ksenia Kasimova, MD; Anna Maria Bombardieri, MD, PhD

Data sourced from clinicaltrials.gov

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