Assessment of Post-operative Residual Curarization (PORC) Incidence in Patients Undergoing Surgery With General Anaesthesia; Comparison Between Cisatracurium and Rocuronium. A Randomised, Single-blind Phase 4 Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of PORC
研究概览
简要总结
The purpose of this study is to determine the incidence of post-operative residual curarization in our patients and to determine if Cisatracurium and Rocuronium behave differently from each other in terms of residual curarization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •general anaesthesia with need to use of neuromuscular-blocking agents
- •awakening and extubation of the patient in the operating room and permanence in the PACU for at least 60 minutes
- •age 18-80
- •surgical operations lasting at least 1 hour
- •ASA class I-III
- •possibility to apply TOF-monitoring with thumb-acceleromyography
- •women of childbearing age not using contraceptives
- •women of childbearing age using contraceptives
排除标准
- •subjects unable to give a valid consent
- •patients in emergency situations
- •patients not awakened and not extubated in the operating room
- •age above 80 years or under 18 years
- •surgical operations lasting less than an hour
- •ASA class IV
- •impossibility to apply and/or perform TOF-monitoring
- •neuromuscular diseases
- •intake of therapies interfering with the neuromuscular function
- •patients having contraindications for either studied drug
- •pregnant women
- •women who are breast-feeding
研究组 & 干预措施
Cisatracurium
Induction and maintaining of anaesthesia with Propofol. Analgesia either with Fentanyl or Fentanyl+Remifentanyl.
Cisatracurium (Nimbex):
- initial dose: 0.2 mg/kg
- maintaining dose: 0.1 mg/kg (repeated anytime TOF-count reaches 2 twitches)
At the end of the surgical operation, patients will be administered Neostigmine 0.04 mg/kg and Atropine 0.02 mg/kg.
Patients will be extubated with a TOF-Ratio of at least 0.90.
干预措施: Cisatracurium (Drug)
Rocuronium
Induction and maintaining of anaesthesia with Propofol. Analgesia either with Fentanyl or Fentanyl+Remifentanyl
Rocuronium (Esmeron):
- initial dose: 0.6 mg/kg
- maintaining dose: 0.15 mg/kg (repeated anytime TOF-count reaches 2 twitches)
At the end of the surgical operation, patients will be administered Neostigmine 0.04 mg/kg and Atropine 0.02 mg/kg.
Patients will be extubated with a TOF-Ratio of at least 0.90.
干预措施: Rocuronium (Drug)
结局指标
主要结局
Incidence of PORC
时间窗: Participants will be followed for the duration of their stay in the post-anaesthesia care unit (PACU), an expected average of 60 minutes.
To determine the incidence of post-operative residual curarization in our operating rooms, comparing two different neuromuscular-blocking agents: Cisatracurium and Rocuronium. The primary endpoint is quantified with TOF-Ratio, determined with the device TOF-Watch SX (Organon, Netherlands). A TOF-Ratio\<0.90 defines PORC. Three clinical parameters (head-tilt for 5 seconds, ability to swallow, presence of diplopia) are also evaluated. TOF-Ratios, as long as the above-mentioned clinical parameters are determined and evaluated at 15, 30 and 60 minutes after extubation of the patient.
次要结局
- Incidence of PORC - comparison between Cisatracurium and Rocuronium(Participants will be followed for the duration of their stay in the post-anaesthesia care unit (PACU), an expected average of 60 minutes.)
研究者
Dr. Paolo Feltracco
Principal Investigator
Azienda Ospedaliera di Padova