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Comparison Between Cisatracurium and Rocuronium in Terms of Recovery of the Muscular Strength in the Postoperative Phase After Surgery and General Anaesthesia

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ClinicalTrials.gov Identifier: NCT01651572
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Paolo Feltracco, Azienda Ospedaliera di Padova

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Residual Curarization Residual Neuromuscular Block Drug: Cisatracurium Drug: Rocuronium Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : July 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Drug: Cisatracurium

Cisatracurium (Nimbex):

  • initial dose: 0.2 mg/kg
  • maintaining dose: 0.1 mg/kg (repeated anytime TOF-count reaches 2 twitches)
Experimental: 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.

 Drug: Rocuronium

Rocuronium (Esmeron):

  • initial dose: 0.6 mg/kg
  • maintaining dose: 0.15 mg/kg (repeated anytime TOF-count reaches 2 twitches)


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of PORC - comparison between Cisatracurium and Rocuronium [ 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • pregnant women
  • women who are breast-feeding
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651572


Locations
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Italy
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Investigators
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Study Chair: Carlo Ori, Prof. M.D. Università degli Studi di Padova - Azienda Ospedaliera di Padova
Principal Investigator: Paolo Feltracco, M.D. Azienda Ospedaliera di Padova
More Information
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Responsible Party: Dr. Paolo Feltracco, Principal Investigator, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT01651572    
Other Study ID Numbers: 2633Pbis
2012-002398-68 ( EudraCT Number )
CURARI_2012 ( Other Identifier: Comitato Etico dell'Azienda Ospedaliera di Padova )
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014
Keywords provided by Dr. Paolo Feltracco, Azienda Ospedaliera di Padova:
Postoperative residual curarization
Residual neuromuscular block
Complications
 Postoperative
Neuromuscular function
Neuromuscular block
Additional relevant MeSH terms:
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Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes
Rocuronium
Cisatracurium
 Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs