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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Lack of funding and other logistical issues)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
Sponsor:
Information provided by (Responsible Party):
Christopher Connors, MD, Maine Medical Center

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Bupivacaine Other: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Saline
Patients will receive a stellate ganglion block but with 10ml of 0.9% saline.
Other: Saline
Patients will receive a stellate ganglion block using 10 ml of 0.9% saline

Experimental: Treatment
Patients will receive a stellate ganglion block with 10ml of 0.5% bupivacaine
Drug: Bupivacaine
Patients will receive a stellate ganglion block using 10 ml of 0.5% bupivacaine
Other Names:
  • marcaine
  • Sensorcaine




Primary Outcome Measures :
  1. Postoperative atrial fibrillation [ Time Frame: up to 7 days ]
    looking for absence of new onset postoperative atrial fibrillation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
Christopher Connors, MD
Investigators
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Principal Investigator: Chris Connors, MD Spectrum Medical Group, Maine Medical Center

Publications:

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Responsible Party: Christopher Connors, MD, Director of Cardiac Anesthesia, Maine Medical Center
ClinicalTrials.gov Identifier: NCT03269383    
Other Study ID Numbers: 1046118-1
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Christopher Connors, MD, Maine Medical Center:
stellate ganglion block
cardiac surgery
atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents