Evaluation of the effect of Methylphenidate on consciousness in patients with brain damage in intensive care unit
Design
This study is clinical trial and double blind.90 patients with brain damage in ICU in Valiasr Hospital in Arak will inter this study.We will divide patients in 2 groups by simple randomization.Groups are parallel.
Settings and conduct
This study is clinical trial and double blind.90 patients with brain damage in ICU in Valiasr Hospital in Arak will inter this study.Outcome assessor and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:A level of consciousness less than 10, being intuitive
Ages between 16 and 50 years, history of brain injury, absence of spacer lesion in brain scan (hematoma, tumor), no history of seizures, no addiction to psychotropic substances and drugs, no history of amphetamine use, no history of hypertension, ischemic heart disease and diabetes mellitus, heart rate less than 120 times per minute
Exclusion criteria: seizure, arrhythmia, death
Intervention groups
Intervention group: Patients will receive 0.3 milligram in kilogram methylphenidate daily in two divided doses of 6 morning and 2 afternoon.
Control group: Patients will not receive anything.
Main outcome variables
Level of consciousness, severity of illness, duration of ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N128
Registration date:2020-01-10, 1398/10/20
Registration timing:retrospective
Last update:2020-01-10, 1398/10/20
Update count:0
Registration date
2020-01-10, 1398/10/20
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
2018-04-30, 1397/02/10
Expected recruitment end date
2019-12-31, 1398/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Methylphenidate on consciousness in patients with brain damage in ICU
Public title
Evaluation of the effect of Methylphenidate on consciousness in patients with brain damage in ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A level of consciousness less than 10
Being intuitive
Ages between 16 and 50 years
History of brain injury
Absence of spacer lesion in brain scan (hematoma, tumor)
No history of seizures
No addiction to psychotropic substances and drugs
No history of amphetamine use
No history of hypertension, ischemic heart disease and diabetes mellitus
Heart rate less than 120 times per minute
Exclusion criteria:
Seizure
Arrhythmia
Death
Age
From 16 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in two groups A and B.
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-04-29, 1397/02/09
Ethics committee reference number
IR.ARAKMU.REC.1397.025
Health conditions studied
1
Description of health condition studied
Brain damage
ICD-10 code
P11.2
ICD-10 code description
Unspecified brain damage due to birth injury
Primary outcomes
1
Description
Level of consciousness
Timepoint
daily to clearance time
Method of measurement
Glasgow coma scale
2
Description
Illness severity
Timepoint
First and third day and time of discharge
Method of measurement
Apache score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive 0.3 milligram in kilogram methylphenidate daily in two divided doses of 6 morning and 2 afternoon.
Category
Treatment - Drugs
2
Description
Control group: Patients will not receive anything.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Behnam Mahmodie
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mahmodie@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
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
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 Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 68 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Behnam Mahmodie
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street