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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

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


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


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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