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Completed

NCT Number: NCT01651572

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

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.

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Key information

Conditions

Postoperative Residual Curarization Delayed Emergence from Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Residual Neuromuscular Block

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Azienda Ospedaliera di Padova

Padova, 35128, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisatracurium

Drug

Cisatracurium (Nimbex):

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

Rocuronium

Drug

Rocuronium (Esmeron):

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Padova

Other

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 27, 2012
Registry last updated
Mar 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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