Dose Finding Study for Reversal of Vecuronium-induced Neuromuscular Blockade at Train-of-four Ratio 0.3 With Sugammadex and Neostigmine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Time to TOF 0.9 after the administration of reversal agent
研究概览
简要总结
The aim of this study is to estimate the optimal dose of sugammadex and neostigmine reversal of a vecuronium-induced residual neuromuscular block at train-of-four ratio 0.3.
详细描述
Sugammadex is a modified γ-cyclodextrin compound that reverses the neuromuscular blockade produced by steroidal nondepolarizing muscle relaxants such as rocuronium,vecuronium and pipecuronium by encapsulating them, making them unavailable to interact with the nicotinic acetylcholine receptors at the neuromuscular junction.However, residual neuromuscular blocks between reappearance of T4 and train-of-four ratio (TOFR)=0.5 are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.
Unlike neostigmine, sugammadex is efficacious in reversing profound (no responses to either train-of-four (TOF) or posttetanic count stimulation) or deep (posttetanic count of 1 or 2) neuromuscular block (NMB) in doses of 16 and 4 mg/kg, respectively. However, shallow neuromuscular blocks are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 age of 18 to 65 yr,
- •2 body mass index 18.5 to 25.0 kg/m2,
- •3 American Society of Anesthesiologists physical status I to III
- •4 scheduled for elective surgery with an expected duration of at least 60min under general anesthesia with intubation of the trachea or laryngeal mask
- •5 patients having given informed consent to the study
排除标准
- •1 patients who had participated in another clinical trial within 1 month
- •2 Patients with suspected difficult airway, bronchial asthma, chronic obstructive pulmonary disease
- •3 known neuromuscular disease
- •4 suspected malignant hyperthermia
- •5 hepatic or renal dysfunction
- •6 glaucoma
- •7 allergy to the medication that used in this trial
- •8 taking medicaments that might influence the effect of NMB agents
- •9 pregnant, or breastfeeding state
- •10 taking medication known to alter the effect of neuromuscular blocking agents( toremifene .etc)
研究组 & 干预措施
sugammadex 0.125
Sugammadex group: sugammadex 0.125 mg/kg IV once at the reappearance of TOF 0.3
干预措施: Sugammadex (Drug)
Sugammadex 0.25
Sugammadex group: sugammadex 0.25 mg/kg IV once at the reappearance of TOF 0.3
干预措施: Sugammadex (Drug)
Neostigmine 10
Neostigmine group: neostigmine 10 µg/kg IV once at the reappearance of TOF 0.3
干预措施: Neostigmine (Drug)
Sugammadex 0.5
Sugammadex group: sugammadex 0.5 mg/kg IV once at the reappearance of TOF 0.3
干预措施: Sugammadex (Drug)
Sugammadex 1.0
Sugammadex group: sugammadex 1.0 mg/kg IV once at the reappearance of TOF 0.3
干预措施: Sugammadex (Drug)
Sugammadex 2.0
Sugammadex group: sugammadex 2.0 mg/kg IV once at the reappearance of TOF 0.3
干预措施: Sugammadex (Drug)
Neostigmine 25
Neostigmine group: neostigmine 25 µg/kg IV once at the reappearance of TOF 0.3
干预措施: Neostigmine (Drug)
Neostigmine 40
Neostigmine group: neostigmine 40 µg/kg IV once at the reappearance of TOF 0.3
干预措施: Neostigmine (Drug)
Neostigmine 55
Neostigmine group: neostigmine 55 µg/kg IV once at the reappearance of TOF 0.3
干预措施: Neostigmine (Drug)
Neostigmine 70
Neostigmine group: neostigmine 70 µg/kg IV once at the reappearance of TOF 0.3
干预措施: Neostigmine (Drug)
Placebo
Placebo group: Saline 0.9% IV once at the reappearance of TOF 0.3
干预措施: Saline 0.9% (Drug)
结局指标
主要结局
Time to TOF 0.9 after the administration of reversal agent
时间窗: the general anesthesia time 1 hour at least
The time to achieve TOF (Train of Four stimulation) ratio to 0.9 following the investigational drug or placebo administration.
次要结局
- incidence of reparalysis(approximately 1 hour)
- incidence of adverse event(the general anesthesia and recovery time 2 hours at least)
研究者
bo xu
Clinical Professor
Guangzhou General Hospital of Guangzhou Military Command