Comparison Between Cisatracurium and Rocuronium in Terms of Recovery of the Muscular Strength in the Postoperative Phase After Surgery and General Anaesthesia
- Conditions
- Postoperative Residual CurarizationResidual Neuromuscular Block
- Interventions
- Registration Number
- NCT01651572
- Lead Sponsor
- Azienda Ospedaliera di Padova
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cisatracurium 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. Rocuronium 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.
- Primary Outcome Measures
Name Time Method Incidence of PORC 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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy