Effect of Vitamin C on adrenal suppression following etomidate for rapid sequence induction in trauma patients
Design
Phase 2, randomized, parallel clinical trial. Randomization will be done by using randomization program of WWW.randomization.com website. Sample size will be 30 samples in each group.
Settings and conduct
Traumatic patients who need airway management by reapid sequence induction / intubation and admit in Imam Reza hospital, Tabriz, will randomly divide in 2 groups. Prior to intubation blood serum cortisol level will be checked in two groups. Patients in control group will receive 1.5 Mg/Kg lidocain, 2 micg/Kg fentanyl, 0.2 Mg/Kg etomidate and 1.5 Mg/Kg succinylcholin. Intervention group will receive same drugs in same manner but 1 gram of intravenous vitamin C will be injected prior to etomidate injection.
Serum cortisol level will be checked 3 hours after intubation in both groups.
Participants/Inclusion and exclusion criteria
Traumatic patients older than 18 year old who need airway management by using rapid sequence induction/ intubation will included in study.
Corticosteroid users, pregnant patients and patients with a history of endocrine, renal or hepatic disorders will be excluded.
Intervention groups
In control group patients will be intubated by using lidocain, fentanyl, etomidate and succinylcholin.
In intervention group same drugs will used for induction of sedation but patients will receive 1 gram of intravenous Vitamin C prior to etomidate injection.
Main outcome variables
Serum cortisol level three hours after intubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090923002496N11
Registration date:2019-04-19, 1398/01/30
Registration timing:prospective
Last update:2019-04-19, 1398/01/30
Update count:0
Registration date
2019-04-19, 1398/01/30
Registrant information
Name
Hassan Soleimanpour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1329 1286
Email address
soleimanpourh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vitamin C on adrenal suppression following etomidate for rapid sequence induction in trauma patients
Public title
Effect of Vitamin C on adrenal suppression following etomidate for rapid sequence induction in trauma patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Traumatic patients who need rapid sequence induction/ intubation
More than 18 year old
Exclusion criteria:
Corticosteroids users
Pregnant patients
history of endocrine disorders
history of hepatic disorders
history of renal disorders
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A simple method randomization with a unit of individuals will be used. randomization will be done by using randomization program of WWW.randomization.com website.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethic committee of Research Vice chancellor of Tabriz University of Medical Sciences
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Approval date
2019-02-04, 1397/11/15
Ethics committee reference number
IR.TBZMED.REC.1397.925
Health conditions studied
1
Description of health condition studied
Rapid sequence induction/ intubation
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Adrenal suppression
ICD-10 code
E27.3
ICD-10 code description
Drug-induced adrenocortical insufficiency
Primary outcomes
1
Description
Blood cortisol level
Timepoint
Prior to and three hours after to etomidate injection
Method of measurement
Blood serum cortisol level measurement as nano-moles / liter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A single dose of one gram of intravenous Vitamin C will be used. The drug we will use in this study is made by Sobhan pharmaceutical Co. Iran.
Category
Treatment - Drugs
2
Description
Control group: ٌWill receive 5CC of normal saline ass placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Hassan Soleimanpour
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
tbzemrt2014@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Jouyban
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Phone
+98 41 3335 7313
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
soleimanpourh@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
soleimanpourh@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
soleimanpourh@tbzmed.ac.ir
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 collected de identified IPD
When the data will become available and for how long
Data will be available in september 2020.
To whom data/document is available
Data will be available for all interested researchers
Under which criteria data/document could be used
Data will be available for use in other studies. researchers can ask for data of this study by sending email to dr. Hassan Soleimanpour
From where data/document is obtainable
Dr. Hassan Soleinampour soleimanpourh@tbzmed.ac.ir
What processes are involved for a request to access data/document
In two weeks after sending data request email, they can receive data