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

Postoperative Residual Curarization Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651572
• Other study ID #: 2633Pbis
• Secondary ID: 2012-002398-68CU
• Status: Completed
• Phase: Phase 4
• First received: July 23, 2012
• Last updated: March 9, 2014
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: March 2014
• Source: Azienda Ospedaliera di Padova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Residual Curarization
• Residual Neuromuscular Block

Intervention

Drug:
• Cisatracurium
Cisatracurium (Nimbex): initial dose: 0.2 mg/kg maintaining dose: 0.1 mg/kg (repeated anytime TOF-count reaches 2 twitches)
• Rocuronium
Rocuronium (Esmeron): initial dose: 0.6 mg/kg maintaining dose: 0.15 mg/kg (repeated anytime TOF-count reaches 2 twitches)

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera di Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	Yes