Study to Evaluate the Effectiveness of SGB in Preventing Post-op Atrial Fibrillation

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Atrial Fibrillation

In brief

Atrial fibrillation requires both an initiation trigger and favorable environment for maintenance and the sympathetic and parasympathetic nervous systems play important roles in this regard. Unfortunately, the precise mechanisms of post operative atrial fibrillation (POAF) are still being investigated. This postoperative complication has persisted in spite of efforts to mitigate it pharmacologically with beta blockers and amiodarone, an experience shared by most other cardiac surgery centers. The stellate ganglion is formed by the fusion of the inferior cervical sympathetic ganglion and first thoracic sympathetic ganglion. By modulating the sympathetic component of the autonomic nervous system, stellate ganglion stimulation has been shown to facilitate induction of atrial fibrillation while ablation may reduce or prevent episodes. Human studies have further supported this model. Preliminary studies of perioperative stellate ganglion block (SGB) in cardiac surgery suggest that this technique may reduce or prevent episodes of POAF requiring treatment. The investigator's hypothesis is that SGB reduces the incidence of POAF in cardiac surgery populations.

Key facts

Study ID

NCT03269383

Run by

Christopher Connors, MD

People needed

0

Starts

2019-12-01

Expected to finish

2021-12-01

Last updated by the study team

2019-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• scheduled for non-emergent CABG, AVR, or CABG/AVR
• aged at least 18 years
• English speaking

You may not qualify if…

• aged less than 18 years
• pregnant women
• prisoners
• patients having emergency surgery
• 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 as defined by the need for home oxygen)
• patients who are unable to provide informed consent for themselves
• patients with a history of atrial fibrillation

Where it is running

• Maine Medical Center — Portland, Maine, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.