Comparison of neuromuscular blockade’s monitoring and clinical assessment during cisatracurium paralysis in critically ill patients

INTERVENTION: Trade Name: Nimbex®, Cisatracurium 5mg/ml Pharmaceutical Form: Solution for infusion Trade Name: Cisatracurium Hospira, 5mg/ml Pharmaceutical Form: Solution for infusion CONDITION: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] To be able to perform an efficient neuromuscular blockade with the lowest dose of cisatracurium in mechanically ventilated critically ill patients. The neuromuscular blockade is assessed by TOF monitoring or clinical examination. Cisatracurium doses could be changed at any moment during the procedure. PRIMARY OUTCOME: Main Objective: To discover if neuromuscular blockade monitoring by TOF compared with clinical assessment during cisatracurium paralysis reduces the incidence of pharmacological overdose. Primary end point(s): Cisatracurium doses needed per patient per 24h in each group to perform an efficient neuromuscular blockade. Secondary Objective: Does TOF monitoring lead to improved recovery time compared with clinical assessment? Timepoint(s) of evaluation of this end point: From the begining to the end of cisatracurium infusion. SECONDARY OUTCOME: Secondary end point(s): Time to complete withdrawal of neuromuscular blockade. Timepoint(s) of evaluation of this end point: From the end of cisatracurium infusion to complete withdrawal of neuromuscular blockade. INCLUSION CRITERIA: ‐ Age over 18 years ‐ Mechanically ventilated patients ‐ Sedation ‐ Information form waived by family members or surrogates Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5