Cardiac ArrythmiasNCT03450226
Stellate Ganglion Block in Beating Heart Surgery
A study testing stellate ganglion block in people with Cardiac Arrythmias, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cardiac Arrythmias
- What is being tested?
- stellate ganglion block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Stellate Ganglion Block on Hemodynamics Instability During Beating Heart Surgery
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.
Read the 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.
- Conditions
- Cardiac Arrythmias
- Being tested
- stellate ganglion block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stellate ganglion blockDrug
Also called bupivacaine, marcaine
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | patients will receive a stellate ganglion block with 10 ml of 0.25 % bupivacaine Receives: Drug: stellate ganglion block |
| control | No intervention | patients will be controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative electrocardiogram changes
absence of new onset postoperative cardiac arrhythmia and myocardial infarction after off-pump coronary artery bypass surgery
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study startMar 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrythmiasStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara abdallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450226
- Sponsor's protocol ID
- SGB in beating heart surgery
- Status last verified
- Feb 2018
- First submitted
- 19 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stellate Ganglion Block on Hemodynamics Instability During Beating Heart Surgery
- ClinicalTrials.gov ID
- NCT03450226
- Acronym / sponsor ID
- SGB in beating heart surgery
- Conditions
- Cardiac Arrythmias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: stellate ganglion blockpatients will receive a stellate ganglion block with 10 ml of 0.25 % bupivacaine |
| control | No intervention | –patients will be controlled |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stellate ganglion blockAlso: bupivacaine, marcaineAfter 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. | Drug | treatment |
Primary outcome
postoperative electrocardiogram changes
Time frame: up to 7 days
absence of new onset postoperative cardiac arrhythmia and myocardial infarction after off-pump coronary artery bypass surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing stellate ganglion block in people with Cardiac Arrythmias, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sara abdallah (01009556520, sara92abdallah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative electrocardiogram changes (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.