A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients.
试验速览
- 阶段
- 4 期
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.
研究概览
简要总结
To demonstrate that the use of Sugammadex enables physicians to perform early extubation in the operating room in ASA 4 & 4E patients
Primary endpoint:
• Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.
Secondary endpoints:
• Time to extubation - measure the difference in time from application of the surgical dressing until extubation. Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)
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
- None
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
- •ASA 4 AND ASA 4E patients
- •Patients scheduled to undergo any bowel, urogenital or orthopedic surgery under general anesthesia where use of neuromuscular blocking agents is indicated. -
排除标准
- •Patients ASA 1-3 or 5
- •Patients who have a medical condition which precludes extubation at the end of surgery (i.e., mesenteric event, severe hypothermia etc.).
- •Presence of an advanced directive to withhold or withdraw life sustaining treatment (i.e. DNR).
- •Hypersensitivity to the active substances or to any of the excipients of medications used
- •Patients with severe renal impairment (including patients requiring dialysis (CrCl < 30mL/min))
- •Patients with severe hepatic impairment
- •Age < 18 years
研究组 & 干预措施
Sugammadex (tradename Bridion)
干预措施: Sugammadex Reversal (Drug)
Traditional reversal or spontaneous recovery:
Atropine/Neostigmine: Atropine, 0.02 mg/ kg, and Neostigmine,0.05 mg/kg diluted in 100 ml Normal Saline and given over a 10 min drip. Reversal will be given only recommended if spontaneous recovery has occurred up to the reappearance of T2 (shallow blockade) following rocuronium induced blockade.
干预措施: Atropine/Neostigmine (Drug)
结局指标
主要结局
Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.
时间窗: 24 hours
次要结局
- Time to extubation - measure the difference in time from application of the surgical dressing until extubation.(24 hours)
- Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)(24 hours)