Cisatracurium generic vs original brand-name

Compared efficacy and tolerance of the neuromuscular blockade induced by original brand-name (Nimbex®) and generic (Cisatrex®) of cisatracurium in mechanically ventilated critically ill patients: A crossover double-blind randomized study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN89942618

Enrollment

Registered

2017-10-30

Start date

2016-07-01

Completion date

Unknown

Last updated

2023-12-04

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

Conditions

Patients admitted to ICU, under optimized sedation and ventilation, for hypoxemic acute respiratory failure with a PaO2/FIO2 < 200 and requiring paralysis to improve gas exanges and offset patient-ventilator asynchronies. Respiratory Hypoxemic acute respiratory failure

Interventions

Participants admitted to the ICU under optimised sedation and ventilation for hypoxemic acute respiratory failure a PaO2/FIO2 < 200 and requiring paralysis to improve gas exanges and offset patient-ve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients admitted to the ICU with severe acute respiratory failure with severe hypoxemia (ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) < 200), 2. Put under invasive mechanical ventilation with important patient-ventilator asynchrony and requiring paralysis despite deep analgo-sedation as assessed by RSS 3. Aged 18 and older

Exclusion criteria

Exclusion criteria: 1. Patients with history of allergy to cisatracurium 2. Malignant hyperthermia 3. Pregnancy 4. Neuromuscular disorders

Design outcomes

Primary

Measure	Time frame
1. Paralysis delay is measured using the train of four (TOF) at baseline and each 5 minutes time interval till 2 hours 2. Recovery time is measured using the TOF after stopping paralysis agent and each 5 minutes time interval till 1 hour	—

Secondary

Measure	Time frame
1. TOF variability is measured using the changes of TOF responses at each interval time within the paralysis period and recovery time 2. Hemodynamic tolerance is measured using the variation in heart rate above 30% of the baseline value and/or a significant drop of systolic and/or diastolic blood pressures above 30% of the baseline values at each 5 minutes 3. Tolerance is measured using Drug interactions mainly with antibiotics, monitored within the 6 hours protocol period	—

Measure

Time frame

1. TOF variability is measured using the changes of TOF responses at each interval time within the paralysis period and recovery time 2. Hemodynamic tolerance is measured using the variation in heart rate above 30% of the baseline value and/or a significant drop of systolic and/or diastolic blood pressures above 30% of the baseline values at each 5 minutes 3. Tolerance is measured using Drug interactions mainly with antibiotics, monitored within the 6 hours protocol period

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Countries

Tunisia

Outcome results

None listed

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