Clinical trial · Interventional
Effect of Magnesium Sulphate Infusion on Lung Mechanics and Oxygenation in COPD Patients Undergoing Total Laryngeal
Effect of Intravenous Infusion of Magnesium Sulphate on Arterial Oxygenation and Pulmonary Mechanics in Patients With Chronic Obstructive Pulmonary Diseases Undergoing Cancer Larynx Surgery. A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Obstructive Pulmonary Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnesium Sulphate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mg-group
- description
- 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).
- interventionNames
- Drug: Magnesium Sulphate
- type
- NO_INTERVENTION
- label
- Control group
- description
- In control group, same rates of infusion for loading and maintenance will be applied using 0.9 normal saline.
Primary outcomes (1)
- measure
- lung oxygenation
- timeFrame
- over a period of 6-8 hours, from the time of induction of general anesthesia until time of patients discharge from the PACU.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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: * 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).
References
Publications (1)
- DERIVEDAhmed 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. PMID 32770840