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
About this trial
This is an interventional prevention trial for Cardiac Arrythmias
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
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
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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