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Completed

NCT Number: NCT04922814

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university, faculty of medicine, anesthesia and ICU and pain management department

Asyut, Asyut Governorate, 71515, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Muscle Relaxation

Drug

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.

Primary outcomes

  1. PaO2/FiO2

    Time frame: 48 hours

    ratio of arterial oxygen pressure in millilitre mercury to fraction of inspired oxygen at same time within the arterial blood gas

Secondary outcomes

  1. Change in lung mechanics

    Time frame: 48 hours

    measurement 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

  2. SOFA score

    Time frame: 48 hours

    Fulfilment of modified SOFA (Sepsis Organ Failure Assessment) score sheet

  3. Measurement of tissue perfusion

    Time frame: 48 hours

    Measurement of tissue perfusion by serum lactate in mmol/L and jugular venous oxygen saturation % from a sample withdrawn from CVP

  4. Monitoring of Alveolar - Arterial Oxygen difference

    Time frame: 48 hours

    An 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]

  5. 28 days survival

    Time frame: after 28 days

    28 days survival

  6. Recording risk factors

    Time frame: 28 days

    Recording risk factors as diabetes, renal failure, immunosuppression, smoking, COPD and obesity

  7. Recording complications

    Time frame: 28 days

    Recording complications as VAP, HAP, neuromuscular weakness

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2021
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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