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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Paolo Feltracco, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier:
NCT01651572
First received: July 23, 2012
Last updated: March 9, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Postoperative Residual Curarization
Residual Neuromuscular Block
Drug: Cisatracurium
Drug: Rocuronium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera di Padova:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

    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:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651572

Locations
Italy
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Investigators
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

No publications provided

Responsible Party: Dr. Paolo Feltracco, Principal Investigator, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT01651572     History of Changes
Other Study ID Numbers: 2633Pbis, 2012-002398-68, CURARI_2012
Study First Received: July 23, 2012
Last Updated: March 9, 2014
Health Authority: Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

Keywords provided by Azienda Ospedaliera di Padova:
Postoperative residual curarization
Residual neuromuscular block
Complications
Postoperative
Neuromuscular function
Neuromuscular block

Additional relevant MeSH terms:
Anesthetics
Rocuronium
Atracurium
Cisatracurium
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014