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.

Study Overview

• Status: Completed
• Conditions: ICU Acquired Weakness; Sedation Complication; COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Drug: muscle relaxation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt, 71515
      • Assiut university, faculty of medicine, anesthesia and ICU and pain management department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group(group A); Only sedation for mechanically ventilated COVID patients
Experimental: Muscle relaxant group(group B); 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.	Drug: muscle 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2	ratio of arterial oxygen pressure in millilitre mercury to fraction of inspired oxygen at same time within the arterial blood gas	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lung mechanics	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	48 hours
SOFA score	Fulfilment of modified SOFA (Sepsis Organ Failure Assessment) score sheet	48 hours
Measurement of tissue perfusion	Measurement of tissue perfusion by serum lactate in mmol/L and jugular venous oxygen saturation % from a sample withdrawn from CVP	48 hours
Monitoring of Alveolar - Arterial Oxygen difference	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]	48 hours
28 days survival	28 days survival	after 28 days
Recording risk factors	Recording risk factors as diabetes, renal failure, immunosuppression, smoking, COPD and obesity	28 days
Recording complications	Recording complications as VAP, HAP, neuromuscular weakness	28 days

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.
• Mason RJ. Pathogenesis of COVID-19 from a cell biology perspective. Eur Respir J. 2020 Apr 16;55(4):2000607. doi: 10.1183/13993003.00607-2020. Print 2020 Apr.
• Neto AS, Pereira VG, Esposito DC, Damasceno MC, Schultz MJ. Neuromuscular blocking agents in patients with acute respiratory distress syndrome: a summary of the current evidence from three randomized controlled trials. Ann Intensive Care. 2012 Jul 26;2(1):33. doi: 10.1186/2110-5820-2-33.
• Hohmann F, Wedekind L, Grundeis F, Dickel S, Frank J, Golinski M, Griesel M, Grimm C, Herchenhahn C, Kramer A, Metzendorf MI, Moerer O, Olbrich N, Thieme V, Vieler A, Fichtner F, Burns J, Laudi S. Early spontaneous breathing for acute respiratory distress syndrome in individuals with COVID-19. Cochrane Database Syst Rev. 2022 Jun 29;6(6):CD015077. doi: 10.1002/14651858.CD015077.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Muscle Contraction; Muscle Relaxation
• Other Study ID Numbers: Covid-19 ICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No