RecruitingPhase 2Phase 3NCT05357690

A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

Stellate Ganglion Blockade for the Prevention of Atrial Fibrillation After Cardiac Surgery: A Randomized Placebo-Controlled Trial


Sponsor

Mayo Clinic

Enrollment

220 participants

Start Date

Apr 19, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to test if a nerve block procedure called a stellate ganglion block can help decrease the chance of atrial fibrillation after surgery. Atrial fibrillation is the abnormal, fast beating of the upper chambers of the heart. Stellate ganglion blockade has shown to decrease other types of abnormal heart rhythms as well as decrease the chance of atrial fibrillation.


Eligibility

Min Age: 60 Years

Inclusion Criteria2

  • Patient presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota.
  • Patients scheduled to undergo mitral or aortic valve surgery with or without coronary artery bypass grafting.

Exclusion Criteria10

  • Patients with a history of permanent atrial fibrillation, left or right ventricular assist device implantation or explantation.
  • Patients with procedures not requiring cardiopulmonary bypass.
  • Patients with procedures requiring deep hypothermic circulatory arrest.
  • Patients with active infection or sepsis.
  • Pre-operative immunosuppressive medication use (including steroid use).
  • Pre-operative anti-arrhythmic medication use (aside from beta-blockers).
  • Patients with Immunodeficiency syndrome.
  • Patients with known neurologic disorder.
  • Patients requiring left internal jugular central line placement.
  • Performance of Maze procedures or left atrial appendage ligation procedures will not exclude patients from potential enrollment as atrial fibrillation still occurs postoperatively while the scarring from the Maze procedure forms.

Interventions

PROCEDUREStellate ganglion block

Ultrasound guided injection into the stellate ganglion performed in the right side of the neck in a sterile fashion.

DRUGBupivacaine

10 mL of 0.5% without epinephrine injected in the plane of the right stellate ganglion

DRUGPlacebo

10 mL of saline injected in the plane of the right stellate ganglion


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT05357690


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