Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05908864
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2023-05-26
Brief Title:
Nebulized Versus Intravenous Magnesium Sulfate in Treatment of Asthma Exacerbation
Sponsor:
Beni-Suef University
Organization:
Beni-Suef University
Study Overview
Official Title:
Efficacy of Nebulized Versus Intravenous Magnesium Sulfate in Treatment of Asthma Exacerbation
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective study in Beni-Seuf University Hospital that was conducted on 123 adult patients with acute asthma exacerbations Patients were classified into group I received IV magnesium sulfate group II received nebulized magnesium sulfate and group III control group Blood pressure respiratory rate pulse peak expiratory flow rate PEFR measurement using a peak flowmeter Fischl index and need for hospitalization in patients with acute bronchial asthma were done for all patients before treatment immediately after the treatment 30 and 60 min after treatment
Detailed Description:
Inclusion criteria
adult patients between the ages of 18 and 50 years with acute attack of bronchial asthma
from both sexes
Normal renal function
Normal cardiovascular function
Exclusion criteria
Patients were younger than 18 years or older than 50 years
Patients suffered from chronic obstructive pulmonary disease renal disorder and heart failure
All patients were subjected to complete history taking blood sampling for serum magnesium measurement on admission before the initial treatment and after the initial treatment the patients were randomly separated into 3 equal groups each group consists of 41 patients
The 1ST group has been managed by an initial treatment plan consists of supplemental oxygen therapy to keep oxygen saturation higher than 90 nebulization of 1 ml salbutamol respirator solution mixed with 9 ml normal saline solution for one session Farcolin respirator solution each 20 ml of Farcolin contains Salbutamol sulfate 0121 gm Made in Egypt by Pharco Pharmaceuticals -Alexandria Intravenous administration of hydrocortisone 100 mg for a single dose Solu-Cortef vial contains powder of 100 mg Sodium hydrocortisone sodium succinate dissolved with 2 ml solvent of sterile bacteriostatic water for IV injection Manufactured by Egyptian Int Pharmaceutical Industries co eipico - Egypt Under license of Pfizer plus a single dose 2000 mg of magnesium sulfate prepared by mixing 20 ml of 10 magnesium sulfate 2000 MG 14 manufactured by Memphis Pharmaceuticals and Chemical Industries with 30 ml of distillated water for injection to produce 50 ml of isotonic magnesium sulfate solution 324 MSOML administered intravenously over 1 hour
The 2nd group has been managed by the same initial treatment plan plus a single dose 2000 mg of magnesium sulfate prepared by mixing 20 ml of 10 magnesium sulfate 2000 MG 14 manufactured by Memphis Pharmaceuticals and Chemical Industries with 30 ml of distillated water to produce 50 ml of isotonic magnesium sulfate solution 324 MSOML nebulized using jet nebulizer over 1 hour
The 3rd group has been managed by the same treatment plan Without using magnesium sulfate a control group the following were recorded for each patient at a fixed interval before the initial treatment immediately after the initial treatment 30 and 60 min after the initial treatment
1 blood pressure respiratory rate and pulse rate
2 Peak expiratory flow measurement using peak flow meter
3 Fischl index for relapse and need for hospitalization in patients with acute bronchial asthma 16
adult patients between the ages of 18 and 50 years with acute attack of bronchial asthma
from both sexes
Normal renal function
Normal cardiovascular function
Exclusion criteria
Patients were younger than 18 years or older than 50 years
Patients suffered from chronic obstructive pulmonary disease renal disorder and heart failure
All patients were subjected to complete history taking blood sampling for serum magnesium measurement on admission before the initial treatment and after the initial treatment the patients were randomly separated into 3 equal groups each group consists of 41 patients
The 1ST group has been managed by an initial treatment plan consists of supplemental oxygen therapy to keep oxygen saturation higher than 90 nebulization of 1 ml salbutamol respirator solution mixed with 9 ml normal saline solution for one session Farcolin respirator solution each 20 ml of Farcolin contains Salbutamol sulfate 0121 gm Made in Egypt by Pharco Pharmaceuticals -Alexandria Intravenous administration of hydrocortisone 100 mg for a single dose Solu-Cortef vial contains powder of 100 mg Sodium hydrocortisone sodium succinate dissolved with 2 ml solvent of sterile bacteriostatic water for IV injection Manufactured by Egyptian Int Pharmaceutical Industries co eipico - Egypt Under license of Pfizer plus a single dose 2000 mg of magnesium sulfate prepared by mixing 20 ml of 10 magnesium sulfate 2000 MG 14 manufactured by Memphis Pharmaceuticals and Chemical Industries with 30 ml of distillated water for injection to produce 50 ml of isotonic magnesium sulfate solution 324 MSOML administered intravenously over 1 hour
The 2nd group has been managed by the same initial treatment plan plus a single dose 2000 mg of magnesium sulfate prepared by mixing 20 ml of 10 magnesium sulfate 2000 MG 14 manufactured by Memphis Pharmaceuticals and Chemical Industries with 30 ml of distillated water to produce 50 ml of isotonic magnesium sulfate solution 324 MSOML nebulized using jet nebulizer over 1 hour
The 3rd group has been managed by the same treatment plan Without using magnesium sulfate a control group the following were recorded for each patient at a fixed interval before the initial treatment immediately after the initial treatment 30 and 60 min after the initial treatment
1 blood pressure respiratory rate and pulse rate
2 Peak expiratory flow measurement using peak flow meter
3 Fischl index for relapse and need for hospitalization in patients with acute bronchial asthma 16
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None