Study for the Evaluation of the Effectiveness of Stellate Ganglion Blockade in Preventing Postoperative Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Postoperative atrial fibrillation
研究概览
简要总结
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.
详细描述
The investigator's hypothesis is that perioperative SGB in cardiac surgery will decrease POAF. To address this, the investigator will:
- Recruit 707 patients to undergo perioperative SGB prior to cardiac surgery (CABG, Aortic Valve Replacement, CABG/Aortic Valve Replacement).
- Perform a double blinded post-induction/pre-operative SGB using either 10 mL 0.5% bupivacaine or 10 mL 0.9% normal saline
- Assess the effects on POAF as defined by the Northern New England (NNE) Cardiovascular Disease Study Group.
Significance: If the investigator is able to demonstrate that perioperative SGB in cardiac surgery affects POAF, this simple, low cost and low risk procedure may significantly impact POAF incidence and thereby its attendant morbidity, mortality and costs in this clinical population.
Study subjects 707 patients electively scheduled for aortic valve, coronary revascularization surgery (CABG) or a combination of the two (CABG/AVR) will be recruited and enrolled to receive SGB at the time of surgery. Patients will be introduced to the study by their surgical team and only those providing informed consent to participate will be enrolled. The informed consent document (attached) clearly states that SGB is not currently standard of care.
Randomization The investigator will use NQuery software (Statistical Solutions Ltd., Boston, MA) to create a randomization scheme stratified by the three types of elective surgery: CABG, aortic valve replacement, and CABG plus aortic valve replacement. Patients will be randomized in a 1:1 ratio to receive either SGB (case, injection of 10 mL 0.5% bupivacaine injection) or sham SGB (control, injection of 10 mL 0.9% saline). For each of the three surgery types, treatment assignments will be placed in opaque envelopes, numbered sequentially; these three series of assignments will be maintained in separate surgery-specific boxes. Medications will be unidentified at the time of injection and the anesthesiologists and cardiac surgeons will be blinded to sham versus treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for non-emergent CABG, AVR, or CABG/AVR
- •aged at least 18 years
- •English speaking
排除标准
- •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
研究组 & 干预措施
Saline
Patients will receive a stellate ganglion block but with 10ml of 0.9% saline.
干预措施: Saline (Other)
Treatment
Patients will receive a stellate ganglion block with 10ml of 0.5% bupivacaine
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Postoperative atrial fibrillation
时间窗: up to 7 days
looking for absence of new onset postoperative atrial fibrillation
次要结局
未报告次要终点
研究者
Christopher Connors, MD
Director of Cardiac Anesthesia
MaineHealth