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Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19

Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04922814
Enrollment
40
Registered
2021-06-11
Start date
2021-08-01
Completion date
2022-08-01
Last updated
2025-12-24

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

Conditions

COVID-19 Acute Respiratory Distress Syndrome, ICU Acquired Weakness, Sedation Complication

Brief summary

Many questions about management of COVID-19 are still not answered. So, we recruit this study aiming to evaluate improvement of oxygenation in COVID-19 patients with severe ARDS, to improve morbidity and mortality of ICU covid patients, to participate in understanding of real hidden pathophysiology of COVID-19.

Interventions

DRUGmuscle relaxation

They will receive muscle relaxation treatment for at least 48 hours. Cisatracurium will be given. Short term infusions up to 24 hours will be given in a dose rate of 2-3 mic/Kg/min followed by intervallic shots of 2-5 mg.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Severe ARDS: PaO2/FiO2 \<200, resistant hypoxemia and tachypnoea (RR \> 40 breath/minute) * Not relieved by high frequency nasal canula or CPAP. * Need for invasive mechanical ventilation (uncooperative)

Exclusion criteria

* Patient relatives' refusal * Not mechanically ventilated. * Combination of female, corticosteroids administration and vecuronium muscle relaxant. * Neuromuscular diseases (especially demyelinating diseases).

Design outcomes

Primary

MeasureTime frameDescription
PaO2/FiO248 hoursratio of arterial oxygen pressure in millilitre mercury to fraction of inspired oxygen at same time within the arterial blood gas

Secondary

MeasureTime frameDescription
SOFA score48 hoursFulfilment of modified SOFA (Sepsis Organ Failure Assessment) score sheet
Measurement of tissue perfusion48 hoursMeasurement of tissue perfusion by serum lactate in mmol/L and jugular venous oxygen saturation % from a sample withdrawn from CVP
Monitoring of Alveolar - Arterial Oxygen difference48 hoursAn arterial canula is to be introduced and a quantity of 0.5 ml of blood samples are obtained from radial artery and arterial blood gas analysis are performed after anti-coagulation by heparin. Alveolar-arterial oxygen tension difference: \[P(A-a) DO2\] = \[(Pa-PH2O) × FiO2%-PaCO2-PaO2\] * \[(760-47) × FiO2%-PaCO2-PaO2\] * \[713 × FiO2%-PaCO2-PaO2\]
Change in lung mechanics48 hoursmeasurement of peak and plateau pressures in cm H2O, airway resistance in cm H2O. s/mL, static and dynamic compliance in Litre/cm H2O and positive end expiratory pressure in cm H2O from ventilator settings
Recording risk factors28 daysRecording risk factors as diabetes, renal failure, immunosuppression, smoking, COPD and obesity
Recording complications28 daysRecording complications as VAP, HAP, neuromuscular weakness
28 days survivalafter 28 days28 days survival

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026