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

NCT ID: NCT03461328

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2019-03-20

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.

Conditions

Chronic Obstructive Pulmonary Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Mg-group

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).

Group Type: EXPERIMENTAL

Magnesium Sulphate

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Abeer Ahmed, MD

Assistant Professor of Anesthesia and SICU - Faculty of Medicine - Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anesthesia department - Faculty of medicine- Cairo University

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 32770840 (View on PubMed)

Other Identifiers

N-76-2017

Identifier Type: -

Identifier Source: org_study_id