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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

Primary Purpose

Postoperative Residual Curarization, Residual Neuromuscular Block

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Cisatracurium
Rocuronium
Sponsored by
Azienda Ospedaliera di Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Residual Curarization focused on measuring Postoperative residual curarization, Residual neuromuscular block, Complications, Postoperative, Neuromuscular function, Neuromuscular block

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda Ospedaliera di Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cisatracurium

Rocuronium

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of PORC - comparison between Cisatracurium and Rocuronium

Full Information

First Posted
July 23, 2012
Last Updated
March 9, 2014
Sponsor
Azienda Ospedaliera di Padova
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1. Study Identification

Unique Protocol Identification Number
NCT01651572
Brief Title
Comparison Between Cisatracurium and Rocuronium in Terms of Recovery of the Muscular Strength in the Postoperative Phase After Surgery and General Anaesthesia
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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera di Padova

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Residual Curarization, Residual Neuromuscular Block
Keywords
Postoperative residual curarization, Residual neuromuscular block, Complications, Postoperative, Neuromuscular function, Neuromuscular block

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cisatracurium
Arm Type
Experimental
Arm Description
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.
Arm Title
Rocuronium
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Cisatracurium
Intervention Description
Cisatracurium (Nimbex): initial dose: 0.2 mg/kg maintaining dose: 0.1 mg/kg (repeated anytime TOF-count reaches 2 twitches)
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
Rocuronium (Esmeron): initial dose: 0.6 mg/kg maintaining dose: 0.15 mg/kg (repeated anytime TOF-count reaches 2 twitches)
Primary Outcome Measure Information:
Title
Incidence of PORC
Description
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.
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.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 pregnant women women who are breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Ori, Prof. M.D.
Organizational Affiliation
Università degli Studi di Padova - Azienda Ospedaliera di Padova
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paolo Feltracco, M.D.
Organizational Affiliation
Azienda Ospedaliera di Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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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