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

NCT01651572 | Completed Phase 4

• 3 other identifiers: 2633Pbis2012-002398-68CURARI_2012
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Residual Curarization; Residual Neuromuscular Block

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (1)

• 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.

Study Arms (2)

Cisatracurium

EXPERIMENTAL

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.

Drug: Cisatracurium

Rocuronium

EXPERIMENTAL

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.

Drug: Rocuronium

Interventions

Cisatracurium DRUG

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

Cisatracurium

Rocuronium DRUG

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

Rocuronium

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

Study Sites (1)

Azienda Ospedaliera di Padova

Padua, Padova, 35128, Italy

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

cisatracurium; Rocuronium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Carlo Ori, Prof. M.D.

  Università degli Studi di Padova - Azienda Ospedaliera di Padova

  STUDY CHAIR

• Paolo Feltracco, M.D.

  Azienda Ospedaliera di Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 27, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 11, 2014

Record last verified: 2014-03

Locations

IT (1)