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

NCT03269383 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 1046118-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

stellate ganglion block; cardiac surgery; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Postoperative atrial fibrillation

  looking for absence of new onset postoperative atrial fibrillation

  up to 7 days

Study Arms (2)

Saline

SHAM COMPARATOR

Patients will receive a stellate ganglion block but with 10ml of 0.9% saline.

Other: Saline

Treatment

EXPERIMENTAL

Patients will receive a stellate ganglion block with 10ml of 0.5% bupivacaine

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

Patients will receive a stellate ganglion block using 10 ml of 0.5% bupivacaine

Also known as: marcaine, Sensorcaine

Treatment

Saline OTHER

Patients will receive a stellate ganglion block using 10 ml of 0.9% saline

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Christopher Connors, MD: lead

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

Related Publications (12)

• Mostafa A, El-Haddad MA, Shenoy M, Tuliani T. Atrial fibrillation post cardiac bypass surgery. Avicenna J Med. 2012 Jul;2(3):65-70. doi: 10.4103/2231-0770.102280.

  PMID: 23826549 BACKGROUND

• 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.

  PMID: 24294036 BACKGROUND

• 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.

  PMID: 25262862 BACKGROUND

• 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. doi: 10.1111/j.1399-6576.2006.01260.x.

  PMID: 17378781 BACKGROUND

• 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. doi: 10.1097/00000542-197910000-00015. No abstract available.

  PMID: 314762 BACKGROUND

• Donmez 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. doi: 10.1053/j.jvca.2004.10.008.

  PMID: 16326296 BACKGROUND

• 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.

  PMID: 20580574 BACKGROUND

• 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.

  PMID: 24107689 BACKGROUND

• 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.

  PMID: 22039079 BACKGROUND

• 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.

  PMID: 25040168 BACKGROUND

• 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.

  PMID: 1570888 BACKGROUND

• 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.

  PMID: 20605816 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Chris Connors, MD

  Spectrum Medical Group, Maine Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Cardiac Anesthesia

Model Details: Randomized Controlled Trial with 2 arms, treatment and placebo

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: August 31, 2017
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)