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

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ClinicalTrials.gov Identifier: NCT03461328
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Abeer Ahmed, MD, Cairo University

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Diseases Drug: Magnesium Sulphate Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : October 20, 2018
Estimated Study Completion Date : February 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: 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).
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.

No Intervention: Control group
In control group, same rates of infusion for loading and maintenance will be applied using 0.9 normal saline.



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461328


Contacts
Contact: Abeer Ahmed, MD 01005244590 abeer_ahmed@kasralainy.edu.eg

Locations
Egypt
Anesthesia department - Faculty of medicine- Cairo University Recruiting
Cairo, Egypt
Principal Investigator: Abeer Ahmed, Anesthesia lecturer         
Sponsors and Collaborators
Cairo University

Responsible Party: Abeer Ahmed, MD, Assistant Professor of Anesthesia and SICU - Faculty of Medicine - Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT03461328     History of Changes
Other Study ID Numbers: N-76-2017
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Abeer Ahmed, MD, Cairo University:
magnesium sulphate, chronic obstructive pulmonary diseases

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents