Back to resultsCervical Sympathetic Block in Patients With Cerebral Vasospasm
Primary Purpose
Anesthesia, Local, Cerebral Vasospasm, Subarachnoid Hemorrhage, Aneurysmal
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cervical sympathetic block
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia, Local focused on measuring regional anesthesia, cervical sympathectomy, cerebral blood flow
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cervical sympathetic block
Arm Description
Patients hospitalized in the 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.
Outcomes
Primary Outcome Measures
Cerebral blood flow
Cerebral blood flow as measured by computed tomography perfusion
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).
Secondary Outcome Measures
Cerebral blood flow velocity
Transcranial doppler measurement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05230134
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 27, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Local, Cerebral Vasospasm, Subarachnoid Hemorrhage, Aneurysmal
Keywords
regional anesthesia, cervical sympathectomy, cerebral blood flow
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cervical sympathetic block
Arm Type
Experimental
Arm Description
Patients hospitalized in the 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.
Intervention Type
Procedure
Intervention Name(s)
Cervical sympathetic block
Intervention Description
All participants will get the cervical sympathetic block and catheter under ultrasound guidance.
Primary Outcome Measure Information:
Title
Cerebral blood flow
Description
Cerebral blood flow as measured by computed tomography perfusion
Time Frame
1 hour after the block
Title
Neurological function
Description
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).
Time Frame
Duration of recovery in ICU (1-2 weeks)
Secondary Outcome Measure Information:
Title
Cerebral blood flow velocity
Description
Transcranial doppler measurement
Time Frame
Daily during recovery in ICU (1-2 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Maria Bombardieri, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25128600
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.
Results Reference
background
PubMed Identifier
31401069
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.
Results Reference
background
PubMed Identifier
12649526
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.
Results Reference
background
PubMed Identifier
33472582
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.
Results Reference
background
PubMed Identifier
33725155
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.
Results Reference
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Cervical Sympathetic Block in Patients With Cerebral Vasospasm
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