Objective: To investigate the effect of magnesium sulfate in acute asthma nebulizer. Inclusion criteria: having a history of asthma, a minimum 18 years and maximum 65 years. Exclusion criteria: COPD; kidney disease; CHF; pneumonitis; respiratory disease have underlying. This clinical trial study was conducted on 146 patients in the intervention and control groups. 0,20,40,60 minutes have been spirometry and FEV1 and PEFR values are checked and recorded. Immediately after spirometry, nebulize salbutamol at a dose of 2 / 5cc with magnesium sulfate 1/5 cc (20g / 100cc) in the intervention group and nebulize salbutamol 2 / 5cc with 1 / 5cc in the control group received normal saline. The main outcome variables in both groups were evaluated and compared with the peak flow meter parameters.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111015446N8
Registration date:2015-11-27, 1394/09/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-27, 1394/09/06
Registrant information
Name
Hassan Motamed
Name of organization / entity
Emegency Department , Ahvaz Jundishapour University of Medical Sciences , Ahvaz , Iran
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3079
Email address
motamed-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-03-22, 1393/01/02
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical and Spirometric response between nebulized salbutamol _ magnesium sulfate and nebulized salbutamol alone in acute asthma attack
Public title
Comparison of clinical and Spirometric response between nebulized salbutamol _ magnesium sulfate and nebulized salbutamol alone in acute asthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with clinical and para-clinical asthma has been confirmed; age 18 years and maximum 65 years.
Exclusion criteria: COPD; CHF; pneumonitis, pulmonary disease lightweight, pregnancy, lactation, is febrile, receiving salbutamol 6 hours before the visit.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz University of Medical Sciences
Street address
Research Assistant, Next to central Building, Ahvaz Jundishapur University of Medical Sciences, University town, Ahvaz
City
Ahvaz
Postal code
6135715794
Approval date
2014-03-08, 1392/12/17
Ethics committee reference number
u-92231
Health conditions studied
1
Description of health condition studied
Acute attack asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Clinical state
Timepoint
Before intervention,20,40,60,minutes after intervention
Method of measurement
Base on alert status,talking,wizing,use of respiratory mu
2
Description
Forced Expiratory Volum in First Secend (FEV1)
Timepoint
Before intervention,20,40,60,minutes after intervention
Method of measurement
Mililiter with use of Peak Flow Meter
3
Description
Peak Expiratory Flow Rate(PEFR)
Timepoint
Before intervention,20,40,60 minutes after intervention
Method of measurement
Mililiter with use of Peak Flow Meter
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before intervention,20,40,60 minutes after intervention
Method of measurement
mm Hg
2
Description
Pulse Rate
Timepoint
Before intervention,20,40,60 minutes after intervention
Method of measurement
Rate/Minutes
3
Description
Respiratory Rate
Timepoint
Before intervention,20,40,60 minutes after intervention
Method of measurement
Rate/Minutes
4
Description
Saturation of arterial blood oxygen (SO2 %)
Timepoint
Before intervention,20,40,60 minutes after intervention
Method of measurement
with Pulse Oximetry
Intervention groups
1
Description
The intervention group were recorded at 0, 20, 40, 60 spirometric values of FEV1 and PEFR were measured and recorded. For each patient to record the values of FEV1 and PEFR, 3 times a spirometry performed and is considered the highest number. Immediately after spirometry, nebulize salbutamol dose (2.5 mg), as well as magnesium sulfate 20 g / 100CC) 1.5 CC) done.
Category
Treatment - Drugs
2
Description
The control group were recorded at 0, 20, 40, 60 spirometric values of FEV1 and PEFR were measured and recorded. For each patient to record the values of FEV1 and PEFR, 3 times a spirometry performed and is considered the highest number. Immediately after spirometry, nebulize salbutamol 2 / 5CC (2.5 mg), with 1.5 CC of saline in the control group will receive.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
DR.Hasan Motamed
Street address
Golestan,Ahvaz Golestan Hospital
City
Ahvaz
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
DR.Hasan Motamed
Street address
Imam Khomeini Hospital , 24 metri street, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chanceller for research,Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
DR.Nader Saki
Street address
Research Assistant,Next to center Building,
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanceller for research,Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Emergency Medicine Assistant Professor
Full name of responsible person
DR.Hasan Motamed
Position
Ahvaz Golestan Hospital
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital,Golestan street,Ahvaz
City
Ahvaz
Postal code
613573318
Phone
+98 61 3374 3079
Fax
Email
Hasan_motamed@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Golestan Hospital
Full name of responsible person
DR.Hasan Motamed
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital,Golestan street,Ahvaz
City
Ahvaz
Postal code
613573318
Phone
+98 61 3374 3079
Fax
Email
Hasan_motamed@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Golestan Hospital
Full name of responsible person
DR.Hasan Motamed
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital,Golestan street,Ahvaz
City
Ahvaz
Postal code
613573318
Phone
+98 61333743079
Fax
Email
Hasan_motamed@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)