Efficacy and Safety of Sugammadex (2mg/kg) to Shorten Time-to-extubation Among Postoperative ICU Patients Following AVR, CABG Surgery, or AVR/CABG Surgery- a Prospective Randomized Placebo-controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time to Extubation
研究概览
简要总结
The purpose of this study is to demonstrate faster time to extubation after arrival in the cardiothoracic intensive care unit (ICU) in patients undergoing isolated coronary artery bypass grafting (CABG), AVR and AVR/CABG combination who receive Sugammadex as compared to placebo.
详细描述
Primary Efficacy Objective: To demonstrate faster time to extubation after arrival in the cardiothoracic ICU in patients having a CABG who receive Sugammadex 2mg/kg as compared to placebo.
Hypotheses: We hypothesize that the use of Sugammadex for reversal of residual neuromuscular blockade in adults undergoing CABG, AVR or CABG/AVR combination surgery in the cardiothoracic ICU will significantly decrease the time to extubation.
Prolonged intubation after cardiac surgery continues to be a common clinical challenge and is associated with significant risks and costs(1-5). Despite a Class I recommendation by the American College of Cardiology supporting care directed towards early postoperative extubation after low to medium risk Coronary Artery Bypass Grafting (CABG) surgeries (6), a sizable proportion of patients continue to have a prolonged course of cardiothoracic intensive care unit (CTICU) intubation(1). Residual neuromuscular blockade (NMB) continues to be one of the key factors leading to prolonged intubation after cardiac surgery(7). It is also a significant contributor to postoperative pulmonary and respiratory complications including hypoxia, upper airway obstruction; and decreased oxygen saturation - often prompting reintubation in critical care units(8-10). Due to the profound effects that neuromuscular reversal agents other than Sugammadex have when used in combination with muscarinic acetylcholine receptor antagonists on the autonomic nervous system and patient hemodynamics, these traditional reversal drugs are rarely used in the postoperative cardiac surgery patient population (11) as opposed to other general surgical cases.
Sugammadex, a gamma-cyclodextrin drug, rapidly reverses neuromuscular blockade by encapsulating the non-depolarizing amino steroids agents(12) and is not associated with cardiovascular effects that are commonly seen with traditional NMB reversal agents(13). It can also reverse NMB more quickly and predictably than existing agents(14). However, there have been sporadic reports of hypotension(15), anaphylaxis(16), elongated a PTT(17) with the use of Sugammadex. Additionally, although the FDA currently lists Sugammadex as indicated for reversal of neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery,(18) its use in the post cardiac surgery setting is limited due to lack of supportive data. In this context, the present study aims to test the effectiveness of a pragmatic and broadly applicable care pathway for shortening time to extubation among patients in the cardiothoracic ICU who have undergone isolated CABG, AVR or CABG/AVR combination procedure. The FDA-approved package insert is attached as an appendix to this application.
Study design: Prospective, randomized, double blind, single center placebo-controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All elective ARV, CABG cases, on-pump or off-pump, and CABG/AVR in adult patients with preoperative left ventricular ejection fraction (LVEF) ≥45%.
排除标准
- •Emergency/unplanned cases.
- •EF<45% or moderate /severe RV dysfunction.
- •Estimated GFR < 30 mL/min.
- •Patients on supplemental oxygen at baseline (home oxygen).
- •BMI>40 (calculated as the patient's weight in kilograms divided by the square of the patient's height in meters).
- •Patients with chronic opioid use preoperatively.
- •Patients with known neuromuscular disorders preoperatively.
- •Patients with a known sensitivity to Rocuronium or to Sugammadex.
- •Patients with known cognitive deficits preoperatively.
- •Exclusions after recruitment but prior to randomization:
- •Postoperative Bleeding (chest tube output >100cc/hr ).
- •Treatment of anaphylactoid reaction intraoperatively.
- •Patient's temperature<35.5 or >38.3 degree Celsius at the time of ICU arrival.
- •Determination that the patient will require prolonged mechanical ventilation possibly requiring muscle relaxation based on the intraoperative course and clinical judgment of the study PI or collaborating intensivists.
- •Intraoperative hypoxia or on arrival to the ICU. (Please see Study Flowchart).
- •Cardiac arrest.
- •Sudden arrhythmia (Ventricular tachycardia runs/sudden bradycardia with improper pacemaker detection/function) precluding fast-track extubation protocol.
- •Need for inotrope initiation precluding fast-track protocol.
- •Postoperative ST changes.
研究组 & 干预措施
Sugammadex
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
干预措施: Sugammadex (Drug)
Placebo
Research pharmacy will provide the Sugammadex (2m/kg) vs. Placebo in a syringe.
干预措施: Placebo (Other)
结局指标
主要结局
Time to Extubation
时间窗: Up to 2 weeks
The primary outcome of this study aims to test the time to extubation among patients in the cardiothoracic ICU who have undergone isolated CABG.
次要结局
- RSBI(Upto 2 weeks)
- New Dysrhythmia(Up to 2 weeks)
- Change in Renal Function(Up to 2 weeks)
- Length of Hospital Stay(2 weeks)
- Negative Inspiratory Force(Up to 2 weeks)
- Length of ICU Stay(Up to 2 weeks)
- Postoperative CHF(Up to 2 weeks)