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Completed

NCT Number: NCT05908864

Nebulized Versus Intravenous Magnesium Sulfate in Treatment of Asthma Exacerbation

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Beni-suef university

Banī Suwayf, 62521, Egypt

About this study

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):

  • blood pressure, respiratory rate and pulse rate
  • Peak expiratory flow measurement using peak flow meter.
  • Fischl index for relapse and need for hospitalization in patients with acute bronchial asthma. [16[ .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium sulfate

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

Primary outcomes

  1. Improving pulmonary function tests as PEFR for asthmatic patients

    Time frame: 13 monthes

    Prevention of the progression asthma exacerbation for included subjects

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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