Comparison of the effect of ketamine nebulizer with magnesium sulfate in the treatment of patients with corticosteroid-resistant asthma referred to the emergency department
1. Determine the rate of improvement of PEFR
2. Determining the need for hospitalization
Design
α = 0.05 β = 0.2 ==.35 people in each group This study is a double-blind Block Randomization method and software will be divided into two groups.
Settings and conduct
Environment: Emergency Department of Shahid Rajaei Medical Center, Karaj. Society: Patients with corticosteroid-resistant asthma attack. Two-blind. Infusion in acute attack resistant to corticosteroid therapy using peak flowmetry all in one treatment session and measurement of PEFR, V / S before and 30 and 60 minutes of drug infusion with warning signs and possible side effects of the drug to the patient and readiness For necessary actions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: - Age over 18 years old under 65 years - Corticosteroid resistant asthma attack - No history of allergy to ketamine or sulfamide Exclusion criteria: - Dissatisfaction to participate in the study - Age less than 18 years - More age From 65 years - Weight less than 40 kg - Drug or alcohol poisoning - Active psychiatric illness. History of ketamine allergy
Intervention groups
Intervention group: and patients treated with nebulizerctamine (0.3-0.1 mg / kg) from the target population
Main outcome variables
Comparison of the effect of ketamine nebulizer with magnesium sulfate in the treatment of patients with corticosteroid-resistant asthma attack
1. Determine the rate of improvement of PEFR
2. Determining the need for hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200914048715N1
Registration date:2020-09-20, 1399/06/30
Registration timing:prospective
Last update:2020-09-20, 1399/06/30
Update count:0
Registration date
2020-09-20, 1399/06/30
Registrant information
Name
Kimia Farshadfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3421 4275
Email address
kfarshadfar1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-05, 1399/08/15
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ketamine nebulizer with magnesium sulfate in the treatment of patients with corticosteroid-resistant asthma referred to the emergency department
Public title
Comparison of the effect of ketamine and magnesium sulfate on acute asthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age<65
age<>18
Corticosteroid-resistant asthma attack
No history of allergy to ketamine or sulfamide
Exclusion criteria:
Dissatisfaction with participating in the study
age<18
age>65
weight>40
Drug or alcohol poisoning
Active psychiatric illness
History of ketamine allergy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
People will be randomly divided into two groups. This study is such that patients who are candidates for inclusion in the study, after examination in terms of inclusion and exclusion criteria and obtaining informed consent using Block Randomization and software will be divided into two groups and patients in the first group treated with nebulizers. (0.3-0.1 mg / kg) and the second group will be treated with magnesium sulfate infusion (2 gr (within 20 minutes).
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was double-blind, so that the patient and the researcher were unaware of the status of the two groups assigned to the study. The researcher, who performs clinical and diagnostic measurements, was not aware of the status of individuals, and the statistical consultant was unaware of the allocation of individuals to study groups. Only one observer was aware of the allocation of groups.
There will be two intervention and control groups, with standard treatment for both acute asthma attacks.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics commitee of Alborz University of Medical Sciences
Street address
Karaj - 45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
City
karaj
Province
Alborz
Postal code
3198764653
Approval date
2020-05-30, 1399/03/10
Ethics committee reference number
IR.ABZUMS.REC.1399.080
Health conditions studied
1
Description of health condition studied
asthma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Type of treatment - Hospitalization requirement - Acute refractory asthma attack - PEFR
Timepoint
0-30-60 MIN
Method of measurement
Ketamine protocol - number of patients admitted - peak flowmetry
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: and patients will be treated with nebulizerctamine (0.3-0.1 mg / kg). Before and 30 and 60 minutes after treatment with ketamine nebulizer, PEFR was measured by peak flowmeter in the minutes before and 30 minutes and 60 minutes after treatment with vital signs, Spo2 and recorded in a questionnaire sheet and comparison of two methods by soft Analysis tools will be performed. Control group: Patients who are included in the study according to the inclusion criteria will be treated with magnesium sulfate infusion (2 gr) for 20 minutes. Before, 30 and 60 minutes after magnesium sulfate treatment, PEFR With peak flowmetry in the minutes before, 30 minutes and 60 minutes after treatment with vital signs, Spo2 will be measured and recorded in the questionnaire sheet and the comparison of the two methods will be done through analysis software.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency of Shahid Rajaei Medical Training Center in Karaj
Full name of responsible person
Kimia Farshadfar
Street address
Karaj, Hesarak, Shahid Rajaei St., Shahid Rajaei Educational and Medical Center
City
karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Email
kfarshadfar1995@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
-
Full name of responsible person
-
Street address
-
City
-
Province
Alborz
Postal code
-
Phone
+98 26 3477 7777
Email
KFARSHADFAR1995@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
-
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
mehdi rezari kojani
Position
Emergency medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Karaj, Hesarak, Shahid Rajaei St., Shahid Rajaei Educational and Medical Center
City
karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Email
rezaei.mehdi.md@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
mehdi rezaei kojani
Position
Emergency medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Karaj, Hesarak, Shahid Rajaei St., Shahid Rajaei Educational and Medical Center
City
karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Email
rezaei.mehdi.md@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
mehdi rezaei kojani
Position
Emergency medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Karaj, Hesarak, Shahid Rajaei St., Shahid Rajaei Educational and Medical Center
City
karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Email
rezaei.mehdi.md@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be published after making it unrecognizable
When the data will become available and for how long
Starting from 1/4/1400
To whom data/document is available
University researchers
Under which criteria data/document could be used
In order to use in similar articles
From where data/document is obtainable
1.DR Mehdi Rezaei Kojani
2.Kimia Farshadfar
What processes are involved for a request to access data/document
Apply by e-mail first. After acceptance, access is possible by sending your official document and within about a month.