Study to Evaluate the Effectiveness of SGB in Preventing Post-op Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT03269383|
Recruitment Status : Withdrawn (Lack of funding and other logistical issues)
First Posted : August 31, 2017
Last Update Posted : April 24, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Bupivacaine Other: Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Controlled Trial with 2 arms, treatment and placebo|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Study drugs will be randomized and prepared by the institutional pharmacy. The research coordinator will maintain the log tracking which patients received treatment vs placebo.|
|Official Title:||Study for the Evaluation of the Effectiveness of Stellate Ganglion Blockade in Preventing Postoperative Atrial Fibrillation|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Sham Comparator: Saline
Patients will receive a stellate ganglion block but with 10ml of 0.9% saline.
Patients will receive a stellate ganglion block using 10 ml of 0.9% saline
Patients will receive a stellate ganglion block with 10ml of 0.5% bupivacaine
Patients will receive a stellate ganglion block using 10 ml of 0.5% bupivacaine
- Postoperative atrial fibrillation [ Time Frame: up to 7 days ]looking for absence of new onset postoperative atrial fibrillation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269383
|United States, Maine|
|Maine Medical Center|
|Portland, Maine, United States, 04102|
|Principal Investigator:||Chris Connors, MD||Spectrum Medical Group, Maine Medical Center|