Atrial Fibrillation Clinical Trial
Official title:
Study for the Evaluation of the Effectiveness of Stellate Ganglion Blockade in Preventing Postoperative Atrial Fibrillation
Verified date | April 2019 |
Source | Maine Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - scheduled for non-emergent CABG, AVR, or CABG/AVR - aged at least 18 years - English speaking Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Maine Medical Center | Portland | Maine |
Lead Sponsor | Collaborator |
---|---|
Christopher Connors, MD |
United States,
Al-Atassi T, Toeg H, Malas T, Lam BK. Mapping and ablation of autonomic ganglia in prevention of postoperative atrial fibrillation in coronary surgery: MAAPPAFS atrial fibrillation randomized controlled pilot study. Can J Cardiol. 2014 Oct;30(10):1202-7. doi: 10.1016/j.cjca.2014.04.018. Epub 2014 Apr 19. — View Citation
Bidwai AV, Rogers CR, Pearce M, Stanley TH. Preoperative stellate-ganglion blockade to prevent hypertension following coronary-artery operations. Anesthesiology. 1979 Oct;51(4):345-7. — View Citation
Dönmez A, Tufan H, Tutar N, Araz C, Sezgin A, Karadeli E, Torgay A. In vivo and in vitro effects of stellate ganglion blockade on radial and internal mammary arteries. J Cardiothorac Vasc Anesth. 2005 Dec;19(6):729-33. — View Citation
Garneau SY, Deschamps A, Couture P, Levesque S, Babin D, Lambert J, Tardif JC, Perrault LP, Denault AY. Preliminary experience in the use of preoperative echo-guided left stellate ganglion block in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):78-84. doi: 10.1053/j.jvca.2010.03.007. Epub 2010 Jun 30. — View Citation
Gopal D, Singh NG, Jagadeesh AM, Ture A, Thimmarayappa A. Comparison of left internal mammary artery diameter before and after left stellate ganglion block. Ann Card Anaesth. 2013 Oct-Dec;16(4):238-42. doi: 10.4103/0971-9784.119161. — View Citation
Haest K, Kumar A, Van Calster B, Leunen K, Smeets A, Amant F, Berteloot P, Wildiers H, Paridaens R, Van Limbergen E, Weltens C, Janssen H, Peeters S, Menten J, Vergote I, Morlion B, Verhaeghe J, Christiaens MR, Neven P. Stellate ganglion block for the management of hot flashes and sleep disturbances in breast cancer survivors: an uncontrolled experimental study with 24 weeks of follow-up. Ann Oncol. 2012 Jun;23(6):1449-54. doi: 10.1093/annonc/mdr478. Epub 2011 Oct 29. — View Citation
Kumar N, Thapa D, Gombar S, Ahuja V, Gupta R. Analgesic efficacy of pre-operative stellate ganglion block on postoperative pain relief: a randomised controlled trial. Anaesthesia. 2014 Sep;69(9):954-660. doi: 10.1111/anae.12774. Epub 2014 Jul 7. — View Citation
Mostafa A, El-Haddad MA, Shenoy M, Tuliani T. Atrial fibrillation post cardiac bypass surgery. Avicenna J Med. 2012 Jul;2(3):65-70. — View Citation
Stoller JK, Panos RJ, Krachman S, Doherty DE, Make B; Long-term Oxygen Treatment Trial Research Group. Oxygen therapy for patients with COPD: current evidence and the long-term oxygen treatment trial. Chest. 2010 Jul;138(1):179-87. doi: 10.1378/chest.09-2555. Review. — View Citation
Wulf H, Maier C. [Complications and side effects of stellate ganglion blockade. Results of a questionnaire survey]. Anaesthesist. 1992 Mar;41(3):146-51. German. — View Citation
Yildirim V, Akay HT, Bingol H, Bolcal C, Iyem H, Doganci S, Demirkilic U, Tatar H. Pre-emptive stellate ganglion block increases the patency of radial artery grafts in coronary artery bypass surgery. Acta Anaesthesiol Scand. 2007 Apr;51(4):434-40. — View Citation
Zhou Q, Hu J, Guo Y, Zhang F, Yang X, Zhang L, Xu X, Wang L, Wang H, Hou Y. Effect of the stellate ganglion on atrial fibrillation and atrial electrophysiological properties and its left-right asymmetry in a canine model. Exp Clin Cardiol. 2013 Winter;18(1):38-42. — View Citation
* Note: There are 12 references in all — Click here to view all references
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---|---|---|---|---|
Primary | Postoperative atrial fibrillation | looking for absence of new onset postoperative atrial fibrillation | up to 7 days |
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