Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-based Neurointerventional Procedures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent
研究概览
简要总结
The aim of this study is to evaluate whether the use of Sugammadex for reversing the neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed recovery of neuromuscular function. Half of participates will receive Neostigmine with glycopyrrolate, while the other half will receive Sugammadex.
详细描述
Incomplete recovery from neuromuscular blocking agents (NMBAs) residual block after anesthesia and surgery continues to be a common problem in the postanesthesia care (PACU).
Neostigmine remains the most common acetylcholinesterase inhibitor in the United States. However, administration of the drug significantly impairs genioglossus muscle activity when administered after full recovery from neuromuscular block. Moreover, doses of neostigmine exceeding 0.06 mg/kg increase the risk of respiratory complications independent of NMBAs effects.
Sugammadex is a modified γ-cyclodextrin that rapidly reverses that effect of the steroidal nondepolarizing NMBAs rocuronium and vecuronium. Sugammadex forms a stable, inactive 1:1 complex with rocuronium or vecuronium, reducing the amount of free NMBA available to bind to nicotinic acetylcholine receptors at the neuromuscular junction. Unlike neostigmine, sugammadex completely reverses even dense neuromuscular blocks.
Patients having catheter-based neurointerventional procedures are kept deeply anesthetized. It is common to find patients nearly completely paralyzed at the end of neurointerventional procedures and have a markedly delayed emergence while waiting for muscle function to recover sufficiently to safely antagonize with neostigmine.
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
- Double (Participant, Care Provider)
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
- •Age ≥ 18 years;
- •American Society of Anesthesiologists (ASA) physical status 1-3;
- •Scheduled for catheter-based neurointerventional procedures including coiling and stent insertion;
- •General anesthesia.
排除标准
- •Suspected difficult intubation;
- •Neuromuscular disorder;
- •Renal impairment creatinine ≥ 2 mg /dl;
- •Hepatic dysfunction;
- •History of malignant hyperthermia;
- •Allergy to neuromuscular blocking drugs, Sugammadex, neostigmine or glycopyrrolate;
- •Perioperative respiratory infections and/or pneumonia;
- •Intubated or unresponsive;
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Sugammadex
Sugammadex 4 mg/kg at the end surgery
干预措施: Sugammadex (Drug)
Neostigmine with glycopyrrolate
Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery
干预措施: Neostigmine (Drug)
Neostigmine with glycopyrrolate
Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery
干预措施: Glycopyrrolate (Drug)
结局指标
主要结局
Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent
时间窗: within 90 minutes after endotracheal extubation
The primary outcome was a time-to-TOF ratio ≥ 0.9 after the administration of the reversal agent. The TOF ratio was measured in a continuous manner every 12 seconds from the administration of the reversal drug until TOF ratio ≥ 0.9 or until 90 minutes after administration of the reversal agent.
TOF Ratio at 90 Min
时间窗: at 90 minutes after the administration of the reversal agent
TOF (train of four), also known as a peripheral nerve stimulator, is used to assess nerve function in patients receiving neuromuscular blocking agents (paralytic medications). Before giving the medications, the baseline must be measured because this tells how much electrical stimulation the patient needs for nerve stimulation without any paralytic on board. Our primary outcome TOF ratio between TOF at 90 minutes after the administration of the reversal agent versus the TOF at baseline tells us how well the treatment is working to reverse the rocuronium Neuromuscular. This is a sensitivity analysis of primary analysis.
次要结局
- The Time for Extubation After Administration of Reversal Agents(Up to 4 hours after administration of reversal agents)
- Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s(from baseline to 90 minutes after the administration of reversal agent)
- Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s(from baseline to 90 minutes after the administration of the reversal agent)
研究者
Ehab Farag, MD
Ehab Farag, M.D.
The Cleveland Clinic