Nebulized Versus Intravenous Magnesium Sulfate in Treatment of Asthma Exacerbation

Asthma Attack Clinical Trial

Official title:

Efficacy of Nebulized Versus Intravenous Magnesium Sulfate in Treatment of Asthma Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05908864
• Other study ID #: #FWA00015574
• Status: Completed
• Start date: October 30, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: June 2023
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 0.121 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. (e.i.p.i.co.) - 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 MSOM/L) 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 MSOM/L). 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[ .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 15, 2020
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

• Patidnts suffered from renal disorder

• Patients with heart failure.

Related Conditions & MeSH terms

• Asthma
• Asthma Attack

Intervention

Drug:
• Magnesium sulfate
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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Beni-suef university	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improving pulmonary function tests as PEFR for asthmatic patients	Prevention of the progression asthma exacerbation for included subjects	13 monthes