Nebulized Versus Intravenous Magnesium Sulfate in Treatment of Asthma Exacerbation

NCT ID: NCT05908864

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 123 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-30
• Study Completion Date: 2020-12-15

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 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[ .

Conditions

Asthma Attack

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

IV Magnesium Sulfate

Magnesium sulfate

Intervention Type: DRUG

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

Inhaled Magnesium Sulfate

Magnesium sulfate

Intervention Type: DRUG

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

Control group

Magnesium sulfate

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Raghda R.S. Hussein

Assistant Professor of Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine Beni-suef university

Banī Suwayf, , Egypt

Countries

Egypt

Other Identifiers

#FWA00015574

Identifier Type: -

Identifier Source: org_study_id