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

NCT03461328 | Completed Phase 4

• 1 other identifier: N-76-2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

magnesium sulphate, chronic obstructive pulmonary diseases

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Mg-group

EXPERIMENTAL

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).

Drug: Magnesium Sulphate

Control group

NO INTERVENTION

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

Interventions

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.

Mg-group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Anesthesia department - Faculty of medicine- Cairo University

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32770840 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and SICU - Faculty of Medicine - Cairo University

Model Details: 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

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 12, 2018
• Study Start: April 20, 2018
• Primary Completion: October 20, 2018
• Study Completion: March 20, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

EG (1)