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

Azienda Ospedaliera di Padova120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

120

Conditions

Postoperative Residual Curarization Residual Neuromuscular Block

Interventions

CisatracuriumDRUG

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

RocuroniumDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (1)

Azienda Ospedaliera di Padova

Padua, Padova, Italy

Outcomes

Primary Outcomes

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.

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 Outcomes

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.

Data from ClinicalTrials.gov

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