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

Study Overview
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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.

Official Title
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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.

Conditions
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Postoperative Residual Curarization, Residual Neuromuscular Block

Intervention / Treatment
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* Drug: Cisatracurium
* Drug: Rocuronium


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cisatracurium<br>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<br>* Cisatracurium (Nimbex): initial dose: 0.2 mg/kg maintaining dose: 0.1 mg/kg (repeated anytime TOF-count reaches 2 twitches)<br>|
| Experimental: Rocuronium<br>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<br>* Rocuronium (Esmeron): initial dose: 0.6 mg/kg maintaining dose: 0.15 mg/kg (repeated anytime TOF-count reaches 2 twitches)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative residual curarization, Residual neuromuscular block, Complications, Postoperative, Neuromuscular function, Neuromuscular block