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

University of Padua

Status and phase: Completed; Phase 4

Conditions: Postoperative Residual Curarization; Residual Neuromuscular Block

Treatments: Drug: Cisatracurium; Drug: Rocuronium

Study type: Interventional

Funder types: Other

Identifiers

NCT01651572

2633Pbis

2012-002398-68 (EudraCT Number)

CURARI_2012 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

Cisatracurium

Experimental group

Description:

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.

Treatment:

Drug: Cisatracurium

Rocuronium

Experimental group

Description:

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.

Treatment:

Drug: Rocuronium