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.
Overview
- Phase
- Phase 4
- Intervention
- Cisatracurium
- Conditions
- Postoperative Residual Curarization
- Sponsor
- Azienda Ospedaliera di Padova
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Incidence of PORC
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Dr. Paolo Feltracco
Principal Investigator
Azienda Ospedaliera di Padova
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Cisatracurium
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.
Intervention: Rocuronium
Outcomes
Primary Outcomes
Incidence of PORC
Time Frame: 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 Outcomes
- 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.)