Comparison the effects of etomidate versus ketamine on outcome of adult patients with multiple trauma requiring rapid sequence intubation
Design
In this double-blind clinical trial study, there are two study regimens: ketamine and etomidate which are used as induction agents at the emergency department for critical patients requiring rapid sequence intubation. 80 patients according to the inclusion and excluding criteria enter the study and are randomized by specifying a code and using a randomized numeric table.
Settings and conduct
Adult patients with multiple trauma in critical clinical conditions requiring tracheal intubation at the emergency department enter the study and drug regimens which have been filled in syringes (with special blinded codes) are administered to the patients by the nurse for induction of anesthesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All multiple trauma adult patients referring to emergency department of Kowsar hospital requiring rapid sequence tracheal intubation because of decreased level of consciousness or ineffective breathing or circulatory shock.
Exclusion criteria:
drug allergy;
elevated intracerebral or intraocular pressure;
hypertension (Blood Pressure>= 160/110 mm Hg);
severe endocrine disorders (hyperthyroidism, adrenal insufficiency);
active lung disease;
tracheal stenosis;
obstructive sleep apnea;
airway obstruction;
laryngospasm;
pregnancy or lactation.
Intervention groups
1-Ketamine 2- etomidate
Main outcome variables
death at emergency department or during hospital admission, duration of survival days during hospital admission, ventilator free days, ICU-free days, vasopressor-free days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171106037280N3
Registration date:2019-01-28, 1397/11/08
Registration timing:registered_while_recruiting
Last update:2019-01-28, 1397/11/08
Update count:0
Registration date
2019-01-28, 1397/11/08
Registrant information
Name
hamed sotoude
Name of organization / entity
Kurdistan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 2027
Email address
h-sotude@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of etomidate versus ketamine on outcome of adult patients with multiple trauma requiring rapid sequence intubation
Public title
The effects of etomidate and ketamine on outcome of adult patients with multiple trauma requiring tracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All adult multiple trauma patients referring to Sanandaj Kowsar Hospital emergency department requiring rapid sequence tracheal intubation
Exclusion criteria:
allergy to drugs
elevated intracerebral or intraocular pressure
hypertention (Blood Pressure>= 160/110 mm Hg)
severe endocrine disorders
active lung disease
tracheal stenosis
obstructive sleep apnea
airway obstruction
laryngospasm
pregnancy or lactation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization with allocating random numbers to patients and selecting the drug based on that number.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and medications are marked with numbers which are unknown for patients and investigators, at the end of the study it is revealed that which number is representative of which medication for each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Research Department
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
IR.MUK.REC.1396/376
Health conditions studied
1
Description of health condition studied
intubation in trauma patient
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Death at emergency department or during admission at hospital
Timepoint
During emergency department and hospital admission
Method of measurement
Death declaration at his/her documents
2
Description
Duration of survival days during hospital admission
Timepoint
During emergency or hospital admission (from admission and intubation until death)
Method of measurement
Number of survival days
3
Description
ICU-free days
Timepoint
During hospital admission from intubation to 28 days after admission (ICU-discharge point until 28 days after admission)
Method of measurement
Number of ICU-free days
4
Description
Ventilator-free days
Timepoint
During hospital admission from intubation to 28 days after admission (the time of weaning from mechanical ventilation until 28 days after admission)
Method of measurement
Number of ventilator-free days
5
Description
Vasopressor free days
Timepoint
During hospital admission from intubation to 28 days after admission (the time of stopping vasopressor infusion until 28 days after admission)
Method of measurement
Number of vasopressor-free days
Secondary outcomes
1
Description
Number of transfused packed-RBCs
Timepoint
During the first 48 hours from admission
Method of measurement
Number of transfused packed-RBCs documented on patient file
2
Description
Sepsis incidence
Timepoint
During the first 28 days from admission
Method of measurement
Having 2 or more criteria form SIRS associated with an infection focus during the first 28 days from admission
Intervention groups
1
Description
Intervention group1:ketamine: ketamine 3 mg/kg IV infusion, administered once at the beginning of the intervention for induction during rapid sequence intubation.
Category
Treatment - Drugs
2
Description
Intervention group2:etomidate: etomidate 0.3 mg/kg IV infusion, administered once at the beginning of the intervention for induction during rapid sequence intubation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar hospital emergency department
Full name of responsible person
Hamed Sotoude
Street address
Sanandaj, pasdaran st., kowsar hospital, emergency department
City
Sanandaj
Province
Kurdistan
Postal code
6618434683
Phone
+98 87 3366 2027
Email
H-sotude@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Hamed Sotoude
Street address
Sanandaj, pasdaran st., kowsar hospital, emergency department
City
Sanandaj
Province
Kurdistan
Postal code
6618434683
Phone
+98 87 3366 2027
Email
H-sotude@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Hamed Sotoude
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Sanandaj, Pasdaran st., Kowsar hospital, emergency department
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3366 2027
Email
H-sotude@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Hamed Sotoude
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Sanandaj, Pasdaran st., Kowsar hospital, emergency department
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3366 2027
Email
H-sotude@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Hamed Sotoude
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Sanandaj, Pasdaran st., Kowsar hospital, emergency department
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3366 2027
Email
H-sotude@razi.tums.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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The collected data about outcome will be disclosed
When the data will become available and for how long
The data will be published 1 year after the results.
To whom data/document is available
Students and physicians and lecturers
Under which criteria data/document could be used
Data can be used under copyright rules.
From where data/document is obtainable
Data will be in access by sending an e-mail to H-sotude@razi.tums.ac.ir.
What processes are involved for a request to access data/document
The data would be reachable for whom with a qualified letter from research department of their university or institute.