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

Chronic Obstructive Pulmonary Diseases Clinical Trial

— COPD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461328
• Other study ID #: N-76-2017
• Status: Completed
• Phase: Phase 4
• Start date: April 20, 2018
• Est. completion date: March 20, 2019

Study information

• Verified date: August 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 20, 2019
• Est. primary completion date: October 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Diseases
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Magnesium Sulphate
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.

Locations

Country	Name	City	State
Egypt	Anesthesia department - Faculty of medicine- Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lung oxygenation	PaO2/FiO2 immediately after arrival to the PACU	over a period of 6-8 hours, from the time of induction of general anesthesia until time of patients discharge from the PACU.