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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Residual Curarization Residual Neuromuscular Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Cisatracurium

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.

Group Type EXPERIMENTAL

Cisatracurium

Intervention Type DRUG

Cisatracurium (Nimbex):

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

Rocuronium

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.

Group Type EXPERIMENTAL

Rocuronium

Intervention Type DRUG

Rocuronium (Esmeron):

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

Interventions

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Cisatracurium

Cisatracurium (Nimbex):

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

Intervention Type DRUG

Rocuronium

Rocuronium (Esmeron):

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No