Evaluation of methylphenidate effect on level of conciseness and hospital length of stay in patients with severe and moderate traumatic brain injury
Design
Randomization method: Blocks with multiples of 2 and different sizes based on a table of random numbers
Sample size: Based on the same study , Considering the mean and standard deviation of the difference in the amount of accommodation in the special ward in the two groups of Ritalin and placebo equal to 2.5 and 3.5, the sample size in each group is 31 people . Two groups and 31 people in each group
Settings and conduct
Imam Khomeini Hospital, Sari-Individuals with eligibility criteria to enter the study after completing the form of conscious moral satisfaction of the book by block randomization method are assigned to the two groups. Multiple block size of 2 and different In a block, half of the people will be assigned to each of the study groups and the adjustment of the block size is done by randomization software and by an epidemiologist. The mentioned settings are covered for other researchers.
Participants/Inclusion and exclusion criteria
Inclusive Criteria: Moderate to severe brain injury and level of consciousness (GCS) between 5 and 12 that do not require surgery.
Exclusive Criteria:
1. Children under 15
2. Adults over 75 years
3. Very severe trauma, especially in the chest and abdomen
4. Death in the first 48 hours
6. History of untreated heart disease or uncontrolled hypertension
7. Patients with unstable vital signs (fever above 39 degrees - uncontrolled infectious disease - hypotension - acute renal failure and high creatinine ..)
8. Emergency craniotomy
Intervention groups
Moderate to severe brain damage and level of consciousness (GCS) between 5 and 12 that do not require surgery.
Main outcome variables
level of conciseness ; hospital length of stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140915019185N3
Registration date:2020-09-22, 1399/07/01
Registration timing:registered_while_recruiting
Last update:2020-09-22, 1399/07/01
Update count:0
Registration date
2020-09-22, 1399/07/01
Registrant information
Name
kaveh haddadi
Name of organization / entity
mazandaran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1058
Email address
k.haddadi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of methylphenidate on level of conciseness and hospital length of stay in patients with severe and moderate acute traumatic brain injury
Public title
Evaluation of methylphenidate on level of conciseness and hospital length of stay in patients with severe and moderate acute traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to severe brain damage and level of consciousness (GCS) between 5 and 12 that do not require surgery.
Exclusion criteria:
Children under 15
Adults over 75 years
Very severe trauma accompanied by especially chest and abdomen
Death in the first 48 hours
History of untreated heart disease or uncontrolled hypertension
Patients with unstable vital signs (fever above 39 degrees - uncontrolled infectious disease - hypotension - acute renal failure and high creatinine ..)
Emergency craniotomy
Age
From 15 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks with multiples of 2 and different sizes based on a table of random numbers:Blocks with a multiple of 2 and different sizes based on the table of random numbers: Individuals with eligibility criteria to enter the study after completing the form of conscious moral satisfaction of the book by block randomization method are assigned to the two groups. Multiple block size of 2 and different In a block, half of the people will be assigned to each of the study groups and the adjustment of the block size is done by randomization software and by an epidemiologist. The mentioned settings are covered for other researchers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The placebo is designed by a pharmacologist. Due to the same shape and time of use of the drug and the placebo, the patient and the therapist do not know the type of drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Amir Mazandarani Imam Khomeini Hospital
City
sari
Province
Mazandaran
Postal code
48166-33131
Approval date
2020-06-24, 1399/04/04
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1399.037
Health conditions studied
1
Description of health condition studied
moderate and severe brain trauma
ICD-10 code
S06.2X
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
level of conciseness
Timepoint
the days 2,7 and discharge time
Method of measurement
GCS
Secondary outcomes
1
Description
Delirium
Timepoint
Day 2 and day 7 and at discharge
Method of measurement
The incidence of delirium is first assessed by the RASS scale for level of consciousness and then by the CAM-ICU scale for delirium.
Intervention groups
1
Description
Patients with moderate to severe brain injury and level of consciousness (GCS) between 5 and 12 who do not have surgery for hemorrhagic lesion on CT scan.they will receive methylphenydaye.
Category
Treatment - Drugs
2
Description
Control group:Patients with moderate to severe brain injury and level of consciousness (GCS) between 5 and 12 who do not have SURGERY.they will receive placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
Kaveh Haddadi
Street address
Emam Khomeini hospital, Amir Mazandarani Ave
City
SARI
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1630
Fax
+98 11 3336 1630
Email
k.haddadi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saedi
Street address
Moalem Ave
City
SARI
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3325 7230
Fax
+98 11 3325 7230
Email
m.saedi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Kaveh Haddadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Amir Mazandarani Ave
City
SARI
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1630
Fax
+98 11 3336 1630
Email
k.haddadi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Kaveh Haddadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Amir Mazandarani Ave
City
SARI
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1630
Fax
+98 11 3336 1630
Email
k.haddadi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Kaveh Haddadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Amir Mazandarani Ave
City
SARI
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1630
Fax
+98 11 3336 1630
Email
k.haddadi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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