ClinicalTrials.gg
Status unknownNCT03450226Updated Mar 1, 2018

Stellate Ganglion Block in Beating Heart Surgery

An interventional study of stellate ganglion block in Cardiac Arrythmias, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-01.

Sponsored by Assiut University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Cardiac Arrythmias
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients undergoing elective off-pump coronary artery bypass grafting surgery
  • patients with an 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

Exclusion Criteria:

  • emergency surgery
  • patients on thrombolytic therapy
  • patients with coagulation disorders
  • patients requiring heart lung machine
  • patients with clinical 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 )
  • patients with history of atrial fibrillation
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    treatment

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

    Drug: stellate ganglion block

  • No intervention
    control

    patients will be controlled

Interventions

  • 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.

    Also known as: bupivacaine, marcaine

06

What researchers measure

Primary outcomes

  1. postoperative electrocardiogram changes

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

    Time frame: up to 7 days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2018; primary completion for Apr 2019, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2018
First posted
Mar 1, 2018
StartEst.
Mar 2018
Primary completionEst.
Apr 2019
CompletionEst.
Jun 2019
Last update
Mar 1, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03450226
Lead sponsor
Assiut University
Responsible party
sara abdallah (doctor, Assiut University) — Principal investigator
First posted
Mar 1, 2018
Start date
Mar 2018 (estimated)
Primary completion
Apr 2019 (estimated)
Completion
Jun 2019 (estimated)
Last update
Mar 1, 2018

Study contacts

sara abdallah
Contact
sara92abdallah@gmail.com
01009556520

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Bupivacaine

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