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

Conditions: 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.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-000721-31-FR

Lead Sponsor: CHU DE POITIERS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

Exclusion Criteria

-Pregnancy,
-Neuromuscular disorders
-Allergy to cisatracurium, atracurium, benzene sulfonic acid
-Expected survival of less than 2 days
-Personnal or family history of malignant hyperthermia

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To discover if neuromuscular blockade monitoring by TOF compared with clinical assessment during cisatracurium paralysis reduces the incidence of pharmacological overdose.;Secondary Objective: Does TOF monitoring lead to improved recovery time compared with clinical assessment?;Primary end point(s): Cisatracurium doses needed per patient per 24h in each group to perform an efficient neuromuscular blockade.;Timepoint(s) of evaluation of this end point: From the begining to the end of cisatracurium infusion.

Secondary Outcome Measures

Name	Time	Method
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.