Clinical trial NCT03461328: Effect of Magnesium Sulphate Infusion on Lung Mechanics and Oxygenation in COPD Patients Undergoing Total Laryngeal
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Diseases
Keywords: magnesium sulphate, chronic obstructive pulmonary diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-operative intravenous infusion of magnesium sulphate in patients with chronic obstructive pulmonary diseases undergoing total laryngectomy and assess the influence on arterial oxygenation and pulmonary Mechanics in
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
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.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Anesthesia department - Faculty of medicine- Cairo University
Study officials:
References:
citation: 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.