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

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.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Residual Curarization; Residual Neuromuscular Block
• Intervention / Treatment: Drug: Cisatracurium; Drug: Rocuronium

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of PORC	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.	Participants will be followed for the duration of their stay in the post-anaesthesia care unit (PACU), an expected average of 60 minutes.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Padova
• Investigators: Study Chair: Carlo Ori, Prof. M.D., Universita degli Studi di Padova - Azienda Ospedaliera di Padova; Principal Investigator: Paolo Feltracco, M.D., Azienda Ospedaliera di Padova

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 23, 2012
• First Submitted That Met QC Criteria: July 25, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Estimate): March 11, 2014
• Last Update Submitted That Met QC Criteria: March 9, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Complications; Postoperative; Postoperative residual curarization; Residual neuromuscular block; Neuromuscular function; Neuromuscular block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium; Cisatracurium
• Other Study ID Numbers: 2633Pbis; 2012-002398-68 (EudraCT Number); CURARI_2012 (Other Identifier: Comitato Etico dell'Azienda Ospedaliera di Padova)