Reversal of Rocuronium-induced Neuromuscular Block With Sugammadex in Heart Failure Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The time from start of sugammadex administration to recovery of the train-of-four (TOF) ratio to 0.9.
研究概览
简要总结
Although anticholinesterase reversal agents have been used in combination with anticholinergic drugs for over half a century, it has been suggested that they should be used with caution in patients with underlying cardiovascular disease. As sugammadex has no endogenous targets, it is unlikely to cause any adverse cardiovascular effects. This selective relaxant binding agent is specifically designed to encapsulate rocuronium, which can, therefore, promptly restore neuromuscular function regardless of any levels of NMB as the dose is increased.
Some reports, however, suggest that sugammadex may have increased time to effect in some patient populations like the elderly, patients in intensive care and renal failure patients. A less dynamic circulation and increased transfer time to the effector site in these subjects are likely explanations for this effect. The present trial was designed to assess the safety and efficacy of sugammadex 2.0 mg kg-1 for the reversal of rocuronium-induced NMB in patients with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •aged 18 yr or older
- •categorized as American Society of Anesthesiologists class 3-4 and New York Heart Association class 2-4
- •with an ejection fraction <25%
- •scheduled to undergo elective surgery for cardiac resynchronization therapy, an automated implantable cardioverter-defibrillator (ICD), or battery replacement of an ICD or biventricular pacemaker, during general anaesthesia.
排除标准
- •expected to have a difficult intubation for anatomic reasons
- •they had a neuromuscular disorder
- •a personal or family history of malignant hyperthermia
- •or known allergy to medication used during general anaesthesia
- •not able or willing to give written informed consent.
研究组 & 干预措施
Sugammadex
干预措施: Sugammadex (Drug)
结局指标
主要结局
The time from start of sugammadex administration to recovery of the train-of-four (TOF) ratio to 0.9.
时间窗: Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min
次要结局
- The time from start of sugammadex administration to recovery of the TOF ratio to 0.7 and 0.8.(Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min)
- Adverse hemodynamic events.(From anesthesia induction until 3h after arrival in the postanaesthesia care unit (PACU).)
- Adverse respiratory events (SpO2 <90% and/or signs of airway obstruction).(From arrival in the PACU until 30min thereafter.)
研究者
Guy CAMMU
MD, PhD, Staff Anesthesiologist
Onze Lieve Vrouw Hospital