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CompletedNCT03461328COPDUpdated Aug 21, 2019

Effect of Magnesium Sulphate Infusion on Lung Mechanics and Oxygenation in COPD Patients Undergoing Total Laryngeal

A Phase 4 interventional study of Magnesium Sulphate in Chronic Obstructive Pulmonary Diseases, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-21.

Sponsored by Cairo University · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
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Study summary

Chronic Obstructive Pulmonary Disease [COPD] is a major cause of chronic morbidity and mortality worldwide. COPD is characterized by persistent progressive airflow limitation that adversely affects the ventilation/perfusion (V/Q) matching and mechanics of the respiratory muscles and leads to hypoventilation and reduced gas transfer. COPD was identified as a significant comorbidity associated with increased incidences of postoperative pulmonary complications and prolonged hospital stay. MgSO4 either intravenous or inhalational has been shown to promote bronchodilation and to improve lung function in asthmatic patients. MgSO4 either intravenous or inhalational has been shown to promote bronchodilation and to improve lung function in asthmatic patients. Administration of MgSO4 in patients with stable COPD was associated with reduced lung hyperinflation and improvement of respiratory muscle strength. This randomized control trial is designed to assess the effect of intravenous MgSO4 infusion on oxygenation and pulmonary mechanics and incidence of postoperative pulmonary complications and length of hospital stay in patients with COPD undergoing cancer larynx surgery.

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Conditions studied

  • Chronic Obstructive Pulmonary Diseases

Keywords

  • magnesium sulphate, chronic obstructive pulmonary diseases
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In context

Pulmonary Disease, Chronic Obstructive

4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 40 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing cancer larynx surgery (partial laryngectomy, total laryngectomy with or without neck dissection).
  • Age more than 40 years old
  • ASA physical status II and III.
  • Diagnosed as having COPD by preoperative spirometry. The classification is bases on the post-bronchodilators forced expiratory volume in the first second (FEV1). Mild COPD is diagnosed when FEV1 is > 80% of predicted while moderate COPD is diagnosed when FEV1 is \< 80% and > 50% of predicted and sever COPD is diagnosed when FEV1 is \< 50% and > 30% of predicted

Exclusion criteria

Exclusion Criteria:

  • o Patients with heart failure.

    • History with arrhythmias or treatment with antiarrhythmic drugs.
    • Patient with heart block or on beta blockers or calcium channel blockers.
    • Patients with impaired renal function (creatinine > 2)
    • Patients with impaired liver function (ALT more than 2 folds).
    • Patient with combined restrictive and obstructive pulmonary disease.
    • Patients with preoperative tracheostomy.
    • Patients with huge mass obstructing > 50% of the view. (due to its influence on the spirometry measurements).
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Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Mg-group

    10% MgSO4 solution will be used, a loading dose of 30mg/kg over 20 min (equivalent to infusion rate of 0.9 ml/kg/hr for 20 min) will be given followed by continuous infusion of 10mg/kg/hr (equivalent to infusion rate of 0.1ml/kg/hr).

    Drug: Magnesium Sulphate

  • No intervention
    Control group

    In control group, same rates of infusion for loading and maintenance will be applied using 0.9 normal saline.

Interventions

  • intra-operative infusion of of 10% MgSO2 , stating by a laoding dose of 30be used, a loading dose of 30 mg/kg over 20 min followed by continuous infusion of 10 mg/kg/hr accomplish the total laryngectomy.

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What researchers measure

Primary outcomes

  1. lung oxygenation

    PaO2/FiO2 immediately after arrival to the PACU

    Time frame: over a period of 6-8 hours, from the time of induction of general anesthesia until time of patients discharge from the PACU.

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Study locations

1 site
  • Anesthesia department - Faculty of medicine- Cairo University
    Cairo, Egypt
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References and documents

Publications

  • Ahmed A, Sayed AH, Elkholy J, Elshal S, Badwy A, Abdelhamid B, Ollaek M. Intraoperative MgSO4 infusion protects oxygenation and lung mechanics in COPD patients during general anesthesia. A randomized clinical trial. Acta Anaesthesiol Scand. 2020 Nov;64(10):1460-1468. doi: 10.1111/aas.13684. Epub 2020 Aug 16. PubMed 32770840 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03461328
Lead sponsor
Cairo University
Responsible party
Abeer Ahmed, MD (Assistant Professor of Anesthesia and SICU - Faculty of Medicine - Cairo University, Cairo University) — Principal investigator
First posted
Mar 12, 2018
Start date
Apr 20, 2018
Primary completion
Oct 20, 2018
Completion
Mar 20, 2019
Last update
Aug 21, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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