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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-000721-31-FR
Enrollment
Unknown
Registered
2015-09-21
Start date
2013-05-07
Completion date
Unknown
Last updated
2016-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Nimbex®, Cisatracurium 5mg/ml Pharmaceutical Form: Solution for infusion Trade Name: Cisatracurium Hospira, 5mg/ml Pharmaceutical Form: Solution for infusion

Sponsors

CHU DE POITIERS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—

Countries

France

Contacts

Public ContactFanny ABRIAT

CHU DE POITIERS

fanny.abriat@chu-poitiers.fr0549443796

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026