Evaluation of Dizepam on control of acute attack of dyspnea in patients referring to the emergency department
Design
This study is clinical trial and double blind.374 patients with acute attack of dyspnea to reffering emergency department of Valiasr Hospital and Amiral-Momenin Arak Hospital will inter this study.We will divide patients in 2 groups by simple randomization.Groups are parallel.
Settings and conduct
374 patients with acute attack of dyspnea to reffering emergency department of Valiasr Hospital and Amiral-Momenin Arak Hospital will inter this study.Outcome assessor and analyzer don't aware from grouping.We check respiratory distress, level of consciousness and dyspnea.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients with dyspnea, age older than 18 years ,Pco2 less than 0.85 ,level of consciousness is higher than 11
Exclusion criteria: failure to dissatisfaction and follow up
Intervention groups
Control group: Depending on the severity of the dyspnea, they are treated as follows: Use of spray: Salbutamol; Atrovent, injectable corticosteroid use; nebulizer treatment, oxygen therapy, use of injectable beta-agonist, We give diuretic and nitroglycerine serum in patients with symptoms of pulmonary edema.
Intervention group: In addition to the routine treatment in the control group, they are treated with 10 milligram of Diazepam (IV injection within a 3 to 4 minute interval).
Main outcome variables
Respiratory distress, level of consciousness, dyspnea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N122
Registration date:2019-09-30, 1398/07/08
Registration timing:retrospective
Last update:2019-09-30, 1398/07/08
Update count:0
Registration date
2019-09-30, 1398/07/08
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Dizepam on control of acute attack of dyspnea in patients referring to the emergency department
Public title
Effect of Dizepam on control of dyspnea in patients referring to emergency department
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with dyspnea
Age older than 18 years
Pco2 less than 0.85
level of consciousness is higher than 11
Exclusion criteria:
Dissatisfaction
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
374
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number table in division of groups in two groups A and B
Randomization method: Simple randomization.
Random unit: Individual. How to build sequences: First, we will set the framework for our statistical society. We will start from a table point in a row or column. Given the type of code in the row, we will choose the same number of digits. After that, the numbers control the path. We will notice smaller numbers of the statistical community. We will have to continue this work so that the number of samples is complete.Even numbers will use for intervention group and odd numbers will use for the control group.
Allocation concealment:Numbered drug containers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
In order to blind the diazepam and distilled water in two groups, the syringe covered with white paper on which they are written A and B. Syringes are provided to the resident.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-03-04, 1396/12/13
Ethics committee reference number
IR.ARAKMU.REC.1396.310
Health conditions studied
1
Description of health condition studied
Dyspnea
ICD-10 code
R06.0
ICD-10 code description
Dyspnea
Primary outcomes
1
Description
Respiratory distress
Timepoint
Before treatment and up to 40 minutes after treatment
Method of measurement
Physical examination
2
Description
Level of consciousness
Timepoint
Before treatment and up to 40 minutes after treatment
Method of measurement
Glasgow Coma Scale
3
Description
Dyspnea
Timepoint
Before treatment and up to 40 minutes after treatment
Method of measurement
Arterial blood gas test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Depending on the severity of the dyspnea, they are treated as follows: Use of spray: Salbutamol; Atrovent, injectable corticosteroid use; nebulizer treatment, oxygen therapy, use of injectable beta-agonist, We give diuretic and nitroglycerine serum in patients with symptoms of pulmonary edema.
Category
Treatment - Drugs
2
Description
Intervention group: In addition to the routine treatment in the control group, they are treated with 10 milligram of Diazepam (Cspian Co)(IV injection within a 3 to 4 minute interval).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Simin Najaf Gholian
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
najafgholian@arakmu.ac.ir
2
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Simin Najafgholian
Street address
Amiralmomenin hospital, Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
najafgholian@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Vice Chancellor For Research, Arak University Of Medical Science
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Morteza Gharibi
Position
Assistant professor, emergency Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
gharibi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Simin Najafgholian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street