Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03461328
Acronym
COPD
Enrollment
40
Registered
2018-03-12
Start date
2018-04-20
Completion date
2019-03-20
Last updated
2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Diseases

Keywords

magnesium sulphate, chronic obstructive pulmonary diseases

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.

Interventions

DRUGMagnesium 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

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

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
lung oxygenationover 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026