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

NCT ID: NCT04922814

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group(group A)

Only sedation for mechanically ventilated COVID patients

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

muscle relaxation

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ayman Abd El-Khalek Mohammed Glala

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 32269085 (View on PubMed)

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.

Reference Type RESULT
PMID: 22835162 (View on PubMed)

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.

Reference Type RESULT
PMID: 20843245 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35767435 (View on PubMed)

Other Identifiers

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Covid-19 ICU

Identifier Type: -

Identifier Source: org_study_id