Clinical trial NCT05230134: Cervical Sympathetic Block in Patients With Cerebral Vasospasm
Official title: Cervical Sympathetic Block to Increase Cerebral Blood Flow in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anesthesia, Local
Cerebral Vasospasm
Subarachnoid Hemorrhage, Aneurysmal
Keywords: regional anesthesia
cervical sympathectomy
cerebral blood flow
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Patients hospitalized in the intensive care unit (ICU) and developing clinical manifestations of cerebral vasospasm will undergo a computerized tomography (CT) angiography and a CT perfusion scan. If the vasospasm will be confirmed by the CT imaging, 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. A periganglionar catheter will be left in place. A CT angiography and CT perfusion 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cerebral blood flow
timeFrame: 1 hour after the block
measure: Neurological function
timeFrame: Duration of recovery in ICU (1-2 weeks)
Secondary outcomes:
measure: Cerebral blood flow velocity
timeFrame: Daily during recovery in ICU (1-2 weeks)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Anna Maria Bombardieri, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hu N, Wu Y, Chen BZ, Han JF, Zhou MT. Protective effect of stellate ganglion block on delayed cerebral vasospasm in an experimental rat model of subarachnoid hemorrhage. Brain Res. 2014 Oct 17;1585:63-71. doi: 10.1016/j.brainres.2014.08.012. Epub 2014 Aug 13.
citation: Dagistan Y, Kilinc E, Balci CN. Cervical sympathectomy modulates the neurogenic inflammatory neuropeptides following experimental subarachnoid hemorrhage in rats. Brain Res. 2019 Nov 1;1722:146366. doi: 10.1016/j.brainres.2019.146366. Epub 2019 Aug 8.
citation: Treggiari MM, Romand JA, Martin JB, Reverdin A, Rufenacht DA, de Tribolet N. Cervical sympathetic block to reverse delayed ischemic neurological deficits after aneurysmal subarachnoid hemorrhage. Stroke. 2003 Apr;34(4):961-7. doi: 10.1161/01.STR.0000060893.72098.80. Epub 2003 Mar 20.
citation: Zhang J, Nie Y, Pang Q, Zhang X, Wang Q, Tang J. Effects of stellate ganglion block on early brain injury in patients with subarachnoid hemorrhage: a randomised control trial. BMC Anesthesiol. 2021 Jan 20;21(1):23. doi: 10.1186/s12871-020-01215-3.
citation: Pileggi M, Mosimann PJ, Isalberti M, Piechowiak EI, Merlani P, Reinert M, Cianfoni A. Stellate ganglion block combined with intra-arterial treatment: a "one-stop shop" for cerebral vasospasm after aneurysmal subarachnoid hemorrhage-a pilot study. Neuroradiology. 2021 Oct;63(10):1701-1708. doi: 10.1007/s00234-021-02689-9. Epub 2021 Mar 16.