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NCT05230134 Clinical Trial

Cervical Sympathetic Block in Patients With Cerebral Vasospasm

Anesthesia, Local Clinical Trial

Official title:
Cervical Sympathetic Block to Increase Cerebral Blood Flow in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05230134
Other study ID # 64105
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date July 27, 2023
Est. completion date December 2024

Study information
Verified date September 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 10
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cervical sympathetic block
All participants will get the cervical sympathetic block and catheter under ultrasound guidance.

Locations
Country Name City State
United States Stanford University Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cerebral blood flow Cerebral blood flow as measured by computed tomography perfusion 1 hour after the block
Primary Neurological function Change in neurological status as assessed by the Glasgow Coma Scale. The Glasgow Coma Scale score can range from 3 (completely unresponsive) to 15 (responsive). Duration of recovery in ICU (1-2 weeks)
Secondary Cerebral blood flow velocity Transcranial doppler measurement Daily during recovery in ICU (1-2 weeks)
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