Comparison Between Cisatracurium and Rocuronium in Terms of Recovery of the Muscular Strength in the Postoperative Phase After Surgery and General Anaesthesia
Information source: Azienda Ospedaliera di Padova
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Residual Curarization; Residual Neuromuscular Block
Intervention: Cisatracurium (Drug); Rocuronium (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Azienda Ospedaliera di Padova Official(s) and/or principal investigator(s): Carlo Ori, Prof. M.D., Study Chair, Affiliation: Università degli Studi di Padova - Azienda Ospedaliera di Padova Paolo Feltracco, M.D., Principal Investigator, Affiliation: Azienda Ospedaliera di Padova
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: Incidence of PORC
Secondary outcome: Incidence of PORC - comparison between Cisatracurium and Rocuronium
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Azienda Ospedaliera di Padova, Padova 35128, Italy
Additional Information
Starting date: July 2012
Last updated: March 9, 2014
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