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Stellate Ganglion Block in Beating Heart Surgery

Primary Purpose

Cardiac Arrythmias

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stellate ganglion block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Arrythmias

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing elective off-pump coronary artery bypass grafting surgery
  • patients with an ejection fraction of more than 50%
  • creatinine level of less than 2.0 mg / 100 ml
  • no evidence of heart failure
  • no significant chronic obstructive lung disease
  • age of less than 60 years

Exclusion Criteria:

  • emergency surgery
  • patients on thrombolytic therapy
  • patients with coagulation disorders
  • patients requiring heart lung machine
  • patients with clinical contraindications to SGB ( including allergy to local anesthetic , carotid vascular disease as defined by ipsilateral prior carotid endarterectomy or carotid stent, superficial infection at the proposed puncture site, contralateral phrenic or laryngeal nerve palsies , and severe chronic obstructive pulmonary disease )
  • patients with history of atrial fibrillation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    treatment

    control

    Arm Description

    patients will receive a stellate ganglion block with 10 ml of 0.25 % bupivacaine

    patients will be controlled

    Outcomes

    Primary Outcome Measures

    postoperative electrocardiogram changes
    absence of new onset postoperative cardiac arrhythmia and myocardial infarction after off-pump coronary artery bypass surgery

    Secondary Outcome Measures

    Full Information

    First Posted
    February 19, 2018
    Last Updated
    February 27, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03450226
    Brief Title
    Stellate Ganglion Block in Beating Heart Surgery
    Official Title
    Effects of Stellate Ganglion Block on Hemodynamics Instability During Beating Heart Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2018 (Anticipated)
    Primary Completion Date
    April 2019 (Anticipated)
    Study Completion Date
    June 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut 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
    studies suggest that off-pump coronary artery bypass surgery is associated with improved outcomes when compared to on-pump coronary artery bypass. many studies have shown that off-pump coronary bypass surgery reduces patient morbidity and mortality. manipulation of the coronary arteries during cardiac surgery can stimulate the adjacent post-ganglionic sympathetic fibers and mimic stellate ganglion stimulation ,stellate ganglion block (SGB) can interrupt this reflex by decreasing the efferent cervical sympathetic outflows.
    Detailed Description
    when adopting off-pump surgery , the cardiac surgery team must adopt new techniques to handle a beating heart and the variations in hemodynamics that can occur when performing this type of procedure the incidence rate of cardiac arrhythmia occurring during and after surgery is one of the major complication in open heart surgery. in addition , intraoperative hemodynamic disorders, caused by changes in plasma levels of epinephrine and norepinephrine after surgical stimulation , are some of challenges for patients undergoing off-pump coronary artery bypass surgery. hemodynamic disruption leads to myocardial ischemia, resulting in increased incidence of cardiovascular events and mortality. stellate ganglion is formed by the fusion of inferior cervical and first thoracic sympathetic ganglia and is located behind the subclavian artery and anterior to the first rib. the inferior cervical cardiac nerves arise from the medial aspect of the stellate ganglia and provide the cardio-accelerator nerve fibers to the cardiac plexus. stellate ganglion stimulation augments peak systolic pressure, and the enhanced myocardial contractility is secondary to stimulation by postganglionic nerve fibers which traverse from stellate ganglion down the great vessels and along the coronary arteries into the myocardium.the blockage of inferior cervical cardiac nerves is responsible for the bradycardia seen following SGB. SGB has been shown to prevent and control perioperative hypertension induced by increased sympathetic activity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrythmias

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized controlled trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment
    Arm Type
    Experimental
    Arm Description
    patients will receive a stellate ganglion block with 10 ml of 0.25 % bupivacaine
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    patients will be controlled
    Intervention Type
    Drug
    Intervention Name(s)
    stellate ganglion block
    Other Intervention Name(s)
    bupivacaine, marcaine
    Intervention Description
    After induction of general anesthesia, patients will receive a stellate ganglion block using a standard and well described paratracheal technique, The patient's head will be extended and a 4-5-cm, 22-gauge needle inserted at the medial edge of the sternocleidomastoid muscle just below the level of the cricoid cartilage at the level of the transverse process of C6 or C7. After advancing to the transverse process the needle will be withdrawn 2-3 mm prior to injection. A negative aspiration test will be performed in two planes before a 1-ml test dose is used to exclude unintentional intravascular injection (vertebral or subclavian arteries) or subarachnoid injection into the dural sleeve.4 A total of 10 ml of 0.25% bupivacaine will be injected.
    Primary Outcome Measure Information:
    Title
    postoperative electrocardiogram changes
    Description
    absence of new onset postoperative cardiac arrhythmia and myocardial infarction after off-pump coronary artery bypass surgery
    Time Frame
    up to 7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients undergoing elective off-pump coronary artery bypass grafting surgery patients with an ejection fraction of more than 50% creatinine level of less than 2.0 mg / 100 ml no evidence of heart failure no significant chronic obstructive lung disease age of less than 60 years Exclusion Criteria: emergency surgery patients on thrombolytic therapy patients with coagulation disorders patients requiring heart lung machine patients with clinical contraindications to SGB ( including allergy to local anesthetic , carotid vascular disease as defined by ipsilateral prior carotid endarterectomy or carotid stent, superficial infection at the proposed puncture site, contralateral phrenic or laryngeal nerve palsies , and severe chronic obstructive pulmonary disease ) patients with history of atrial fibrillation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    sara abdallah
    Phone
    01009556520
    Email
    sara92abdallah@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Stellate Ganglion Block in Beating Heart Surgery

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