Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 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 examine whether the use of Sugammadex will reduce time from reversal to extubation and improve other post extubation outcomes in Coronary artery bypass grafting patients. This study is a prospective, clinical interventional, randomized single blinded single-center design. The nurses in the cardiac intensive care unit will be blinded to treatment allocation (Group 1 or 2).
详细描述
Enhanced recovery pathways and early extubation of subjects undergoing cardiac procedures has now become mainstay, especially with the advent of minimally invasive procedures .
To facilitate optimal recovery after extubation; muscle strength is vital to prevent reintubation, improved deglutition and quicker transition to lower oxygen requirements, and better respiratory and cardiac hemodynamics. It also expedites de-escalation of acuity of care. Several studies have shown residual muscle weakness after full reversal with neostigmine and glycopyrrolate. Sugammadex is a direct reversal agent and can provide superior muscle strength, which optimizes respiratory function thereby preventing atelectasis, hypoxia and potentially avoiding reintubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
The nurses in the cardiac intensive care unit will be blinded to treatment allocation (Group 1 or 2).
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 70 years
- •American Society of Anesthesiology physical status I-4
- •Isolated coronary artery bypass graft surgery (CABG)
- •Ability to give written informed consent
排除标准
- •Any other surgical procedure concomitant to CABG surgery
- •Known or suspected neuromuscular disease/pre-existing weakness
- •Creatinine clearance less than 30 ml/min
- •Bradycardia of less than 40 beats/min
- •Pregnancy, breastfeeding women
- •Known or suspected allergy to BRIDION® (sugammadex),neostigmine, or rocuronium
- •Patients with contraindications towards sugammadex, neostigmine, or rocuronium
- •Patients included in another trial within the last 30 days
- •Patients with legal guardians or surrogate decision-making
- •Female Patients who refuse to use non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days if receiving sugammadex.
- •Patients undergoing emergency surgery
- •Patient refusal
- •Patients with ejection fraction <30%
- •Patients with restrictive and obstructive lung disease
- •Patients with obstructive sleep apnea
- •Patients with Body Mass Index greater than 40
研究组 & 干预措施
Neostigmine/Glycopyrrolate
Group 1: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage).
干预措施: Rocuronium (Drug)
Neostigmine/Glycopyrrolate
Group 1: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage).
干预措施: Neostigmine (Drug)
Neostigmine/Glycopyrrolate
Group 1: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage).
干预措施: Glycopyrrolate (Drug)
Sugammadex
Group 2: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg).
干预措施: Rocuronium (Drug)
Sugammadex
Group 2: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg).
干预措施: Sugammadex (Drug)
结局指标
主要结局
Time to Extubation
时间窗: 0 minutes of study drug to 3 days after study drug administration
Time to extubation: West Virginia University Hospitals use an electronic medical record (EMR) to chart "procedure stop." The definition for "time to extubation" is from the time the investigators chart "procedure stop" to the time of "extubation".
次要结局
- Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)(0 minutes to 2 hours after study drug administration)
- Tidal Volume(between 30 minutes to 1 hour after extubation)
- Peak Flow Rate(30-60 minutes post-extubation)
- Heart Rate(0 minutes to 2 hours after study drug administration)
- Swallowing Capacity(Between 30 and 60 minutes post-extubation)
研究者
Matthew Ellison
Co-Director Cardiovascular Anesthesiology, Associate Professor
West Virginia University