Decurarization After Thoracic Anesthesia - A Prospective Multicenter Double-blind Randomized Trial Comparing Sugammadex vs Neostigmine Reversal After Thoracic Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9
研究概览
简要总结
At the end of anesthesia it's important to avoid residual neuromuscular block to ensure adequate respiratory function preventing postoperative pulmonary complications. This trial compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine) after thoracic anesthesia. The trial main objective is to demonstrate that sugammadex is faster than neostigmine to reach a Train-of-four-Ratio (TOF-ratio) of 0.9 after thoracic anesthesia, demonstrating that sugammadex allows a faster extubation. Other main purpose is to verify if there is a difference between sugammadex and neostigmine as regards adverse events after extubation and in the postoperative period (until the 30th day after surgery).
Note: TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value during an accelerometric train-of-four stimulation.
详细描述
Patients undergoing thoracic surgery will receive rocuronium as neuromuscular blocking agent. Anesthesia and neuromuscular blockade will be managed freely until the end of surgery. Then patients will be randomized to receive intravenous sugammadex or neostigmine/atropine as follows:
Sugammadex group:
- If Post tetanic count (PTC)=1-15: sugammadex 4 mg/kg
- If at least 1 twitch at the Train-of-four stimulation: sugammadex 2 mg/kg
Neostigmine group:
- If PTC=1-15: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg
- If at least 1 twitch at the Train-of-four (TOF) stimulation: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects scheduled for pulmonary resection, lobectomy, pneumonectomy, bullectomy, pleurodesis
- •Age 18-70 years
- •American Society of Anesthesiologists (ASA) class 1, 2, 3
- •Body mass Index (BMI) = 18-30 kg/m2
排除标准
- •Subjects scheduled for esophagectomy, thoracectomy, vascular resection
- •Chronic Obstructive Pulmonary Disease (COPD) Gold class III e IV, respiratory infection, asthma
- •Preoperative Forced Expiratory Volume in 1 second (FEV1) < 60% of predicted, Forced Expiratory Volume in 1 second/Forced Vital Capacity ratio (FEV1/FVC) <70%
- •Preoperative Diffusion Lung capacity for carbon monoxide/Alveolar Volume ratio (DLCO/VA) < 60% of predicted
- •Preoperative oxygen saturation (SpO2) <92% or Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen (PaO2/FiO2) ratio <300
- •Cardiovascular disease with Metabolic Equivalent of Tasks (METS) score less than 4
- •Neuromuscular disorder
- •Kidney failure defined as Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1,73 m2
- •Pregnant women
研究组 & 干预措施
S Group
Sugammadex 2 or 4 mg/kg iv once at the end of surgery
干预措施: Sugammadex (Drug)
N Group
Neostigmine 0.05 or 0.07 mg/kg (+ atropine 0.02 mg/kg) iv once at the end of surgery
干预措施: Neostigmine (Drug)
结局指标
主要结局
Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9
时间窗: At the end of general anesthesia
Time from reversal administration to at least 3 TOF-ratio value = or \> 0.9
次要结局
- Mean time from reversal administration to TOF-ratio = 1.0(At the end of general anesthesia)
- Mean time from reversal administration to extubation(At the end of anesthesia)
- Muscular weakness incidence(In the first 60 minutes after extubation)
- Hypoxemia or hypercapnia incidence(In the first 60 minutes after extubation)
- Adverse events incidence(In the first 60 minutes after extubation)
- Postoperative complications incidence(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
研究者
Federico Piccioni, MD
Principal Investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano