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Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

Primary Purpose

Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stellate Ganglion Block
Placebo
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Subarachnoid Hemorrhage, Aneurysmal focused on measuring Stellate Ganglion Block, Subarachnoid Hemorrhage, Cerebral Vasospasm, Transcranial Doppler Ultrasonography

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1.Emergency patients with subarachnoid hemorrhage caused by ruptured aneurysm, aged 18-65 years; 2. ASA : II-IV grade, Hunt-Hess : I-III grade 3. For the first case, the operation time is within 24 hours. 4.After signing informed consent, underwent interventional intravascular embolization

Exclusion Criteria:

  • 1. Patients with severe bleeding disorders; 2. Patients with trauma and local infection risk in the nerve block area; 3. Patients with previous aneurysm surgery and unruptured aneurysm; 4. Aneurysm located in middle cerebral artery; 5. Patients with unconsciousness cannot cooperate with the block operation; 6. Those with a history of mental illness and epilepsy; 7. Those who have a history of severe cardiovascular and cerebrovascular diseases and severe organ diseases;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Stellate Ganglion Block

    No Stellate Ganglion Block

    Arm Description

    Experimental patients will receive a stellate ganglion block with 0.25% ropivacaine 10mL on the same side of vasospasm at the level of the sixth cervical vertebrae (C6) before surgery. Patients were then assessed using transcranial Doppler

    patients will receive a stellate ganglion block with 0.9% saline 10mL on the same side of vasospasm at the level of the sixth cervical vertebrae (C6) before surgery. Patients were then assessed using transcranial Doppler

    Outcomes

    Primary Outcome Measures

    The incidence of cerebral vasospasm

    Secondary Outcome Measures

    Full Information

    First Posted
    August 11, 2020
    Last Updated
    September 6, 2020
    Sponsor
    Beijing Tiantan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04512859
    Brief Title
    Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
    Official Title
    Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients With Emergency Aneurysmal Subarachnoid Hemorrhage
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Tiantan Hospital

    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
    To investigate whether the stellate ganglion block is helpful in relieving cerebral vasospasm during aneurysmal coil embolism surgery. The effect was assessed by Transcranial Doppler (TCD).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm
    Keywords
    Stellate Ganglion Block, Subarachnoid Hemorrhage, Cerebral Vasospasm, Transcranial Doppler Ultrasonography

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stellate Ganglion Block
    Arm Type
    Experimental
    Arm Description
    Experimental patients will receive a stellate ganglion block with 0.25% ropivacaine 10mL on the same side of vasospasm at the level of the sixth cervical vertebrae (C6) before surgery. Patients were then assessed using transcranial Doppler
    Arm Title
    No Stellate Ganglion Block
    Arm Type
    Placebo Comparator
    Arm Description
    patients will receive a stellate ganglion block with 0.9% saline 10mL on the same side of vasospasm at the level of the sixth cervical vertebrae (C6) before surgery. Patients were then assessed using transcranial Doppler
    Intervention Type
    Procedure
    Intervention Name(s)
    Stellate Ganglion Block
    Intervention Description
    Stellate ganglion block under ultra-guide will be administered using 0.25% ropivacaine 10mL
    Intervention Type
    Procedure
    Intervention Name(s)
    Placebo
    Intervention Description
    Stellate ganglion block under ultra-guide will be administered using 0.9% saline 10mL
    Primary Outcome Measure Information:
    Title
    The incidence of cerebral vasospasm
    Time Frame
    Change from baseline at 5day,after subarachnoid hemorrhage

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1.Emergency patients with subarachnoid hemorrhage caused by ruptured aneurysm, aged 18-65 years; 2. ASA : II-IV grade, Hunt-Hess : I-III grade 3. For the first case, the operation time is within 24 hours. 4.After signing informed consent, underwent interventional intravascular embolization Exclusion Criteria: 1. Patients with severe bleeding disorders; 2. Patients with trauma and local infection risk in the nerve block area; 3. Patients with previous aneurysm surgery and unruptured aneurysm; 4. Aneurysm located in middle cerebral artery; 5. Patients with unconsciousness cannot cooperate with the block operation; 6. Those with a history of mental illness and epilepsy; 7. Those who have a history of severe cardiovascular and cerebrovascular diseases and severe organ diseases;

    12. IPD Sharing Statement

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