A comparison on effectiveness of Dexmedetomidine and Propofol on serum level of NSE and S100B in patients with traumatic brain injury
Design
A single center, double blind and randomized clinical trial with two parallel groups on 60 patients.
Settings and conduct
Traumatic brain injury patients admitted to ICU of Semnan Kowsar Hospital will be studied. Patients and care providers will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Traumatic Brain Injury patients, intubation in ICU, over 18 years old.
Exclusion criteria: Massive bleeding, acute or chronic renal failure, acute or active liver disease, rheumatologic disorders or auto-immune disease, acute MI, hypersensitivity to drugs, egg and soya
Intervention groups
Intervention group 1: Will receive dexmedetomidine (precedex , Hospira, USA) 1 mcg/kg IV for intubation.
Intervention group 2: Will receive propofol (diprivan, Fresenius Kabi, Germany) 5 mcg/kg IV for intubation.
Main outcome variables
Neuron Specific Enolase (NSE) and S100 Calcium-Binding Protein (S100B)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200824048500N1
Registration date:2021-01-25, 1399/11/06
Registration timing:prospective
Last update:2021-01-25, 1399/11/06
Update count:0
Registration date
2021-01-25, 1399/11/06
Registrant information
Name
Fateme Feizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3624 0902
Email address
fatemefeizi9775@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison on effectiveness of Dexmedetomidine and Propofol on serum level of NSE and S100B in patients with traumatic brain injury
Public title
Effects of Dexmedetomidine and Propofol in brain injury patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Traumatic Brain Injury patients (TBI)
Intubation
In ICU
Over 18 years old
Exclusion criteria:
Massive bleeding
Acute or chronic renal failure
Acute or active liver disease
Rheumatologic disorders or auto-immune disease
Acute MI
Hypersensitivity to drugs or egg and Soya
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups of intervention and control with 30 members using block randomization with block sizes of 2.
Randomized permutation blocks (block 2).
Excel software rand function was used for randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researchers or outcome assessors are unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Basij Blvd , Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-07-28, 1399/05/07
Ethics committee reference number
IR.SEMUMS.REC.1399.146
Health conditions studied
1
Description of health condition studied
Traumatic brain patients
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Neuron Specific Enolase (NSE)
Timepoint
Before intervention and 24hr after intervention
Method of measurement
Elisa
Secondary outcomes
1
Description
S100 calcium-binding protein B (S100B)
Timepoint
Before intervention and 24hr after intervention
Method of measurement
Elisa
Intervention groups
1
Description
Intervention group 1: Will receive dexmedetomidine 1 mcg/kg IV for intubation.(precedex , Hospira , US)
Category
Treatment - Drugs
2
Description
Intervention group 2 : Will receive propofol (diprivan , Fresenius Kabi , Germany) 5 mcg/kg IV for intubation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Bahador Bagheri
Street address
Kowsar Hospital, Amin Blvd., Basij Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3519637452
Phone
+98 23 3345 1336
Email
bagherib@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences, Basij Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3345 1336
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Fateme Feizi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 75, 5th Street, Sepah Avenue, Varamin
City
Varamin
Province
Tehran
Postal code
35147-99442
Phone
+98 21 3624 0902
Fax
Email
fatemefeizi9775@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fateme Feizi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 75,fifth street ,Sepah Ave,Varamin, Tehran
City
Varamin
Province
Tehran
Postal code
35147-99442
Phone
+98 21 3624 0902
Fax
Email
fatemefeizi9775@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fateme Feizi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 75,fifth street ,Sepah Ave,Varamin, Tehran
City
Varamin
Province
Tehran
Postal code
35147-99442
Phone
+98 21 3624 0902
Fax
Email
fatemefeizi9775@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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