Back to resultsEffect of Magnesium Sulphate Infusion on Lung Mechanics and Oxygenation in COPD Patients Undergoing Total Laryngeal (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Diseases
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium Sulphate
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Diseases focused on measuring magnesium sulphate, chronic obstructive pulmonary diseases
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).
Sites / Locations
- Anesthesia department - Faculty of medicine- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mg-group
Control group
Arm Description
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).
In control group, same rates of infusion for loading and maintenance will be applied using 0.9 normal saline.
Outcomes
Primary Outcome Measures
lung oxygenation
PaO2/FiO2 immediately after arrival to the PACU
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03461328
Brief Title
Effect of Magnesium Sulphate Infusion on Lung Mechanics and Oxygenation in COPD Patients Undergoing Total Laryngeal
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
October 20, 2018 (Actual)
Study Completion Date
March 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Diseases
Keywords
magnesium sulphate, chronic obstructive pulmonary diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mg-group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
In control group, same rates of infusion for loading and maintenance will be applied using 0.9 normal saline.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulphate
Intervention Description
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.
Primary Outcome Measure Information:
Title
lung oxygenation
Description
PaO2/FiO2 immediately after arrival to the PACU
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Anesthesia department - Faculty of medicine- Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
32770840
Citation
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.
Results Reference
derived
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Effect of Magnesium Sulphate Infusion on Lung Mechanics and Oxygenation in COPD Patients Undergoing Total Laryngeal
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