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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01651572

Enrollment

120

Registered

2012-07-27

Start date

2012-07-31

Completion date

2013-07-31

Last updated

2014-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Residual Curarization, Residual Neuromuscular Block

Keywords

Postoperative residual curarization, Residual neuromuscular block, Complications, Postoperative, Neuromuscular function, Neuromuscular block

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.

Interventions

DRUGCisatracurium

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

DRUGRocuronium

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of PORC	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

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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026