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

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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Key information

Conditions

Chronic Obstructive Pulmonary Diseases Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anesthesia department - Faculty of medicine- Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Magnesium sulphate

Drug

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.

Primary outcomes

lung oxygenation

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.

PaO2/FiO2 immediately after arrival to the PACU

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Acronym: COPD

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2019
First posted: Mar 12, 2018
Registry last updated: Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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