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

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Diseases

Treatments: Drug: Magnesium Sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT03461328

N-76-2017

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Mg-group

Experimental 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).

Treatment:

Drug: Magnesium Sulphate

Control group

No Intervention group

Description:

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