Comparing the effects of modafinil, methylphenidate and aminophylline on the level of consciousness and weaning from mechanical ventilation in patients with acute traumatic brain injury in intensive care unit
Investigating the effect of modafinil, methylphenidate and aminophylline on the level of consciousness and weaning from mechanical ventilation in patients with acute brain injury in the intensive care unit.
Design
Clinical trial without control group, with parallel groups, double-blind, randomized, phase 2 on 189 patients. Randomization is done using the online program at https://www.sealedenvelope.com/
Settings and conduct
189 patients hospitalized in ICU are included in the study. Patients are randomized into three intervention groups. Mortality rate, duration of hospitalization, time to separation from ventilator and GCS, and disease severity based on APACHI II criteria will be recorded by the Executives on consecutive days from 1 to 9. Due to the double-blindness, the patients, as well as the design analyst and the colleague completing the questionnaires, will be unaware of the division of patients into three groups.
Participants/Inclusion and exclusion criteria
Eligibility: Patients with GCS less than 10 and intubation with acute brain trauma.Conditions for not entering the study: evidence of sensitivity to the study drugs and patient's parents to participate in the study
Intervention groups
Group A: Oral modafinil will be prescribed 100 mg twice a day
Group B: will receive oral methylphenidate 0.3 mg/kg twice a day
Group C: Aminophylline ampoule 2 mg/kg will be given twice a day
Main outcome variables
Duration of patient isolation from ventilator, GCS score and disease severity based on APACHE II criteria on consecutive days 1 to 9 , mortality, duration of hospitalization in ICU
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130719014056N14
Registration date:2024-06-29, 1403/04/09
Registration timing:prospective
Last update:2024-06-29, 1403/04/09
Update count:0
Registration date
2024-06-29, 1403/04/09
Registrant information
Name
Hesameddin Modir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 9680
Email address
he_modir@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-25, 1403/06/04
Expected recruitment end date
2025-02-22, 1403/12/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of modafinil, methylphenidate and aminophylline on the level of consciousness and weaning from mechanical ventilation in patients with acute traumatic brain injury in intensive care unit
Public title
Investigating the effect of modafinil, methylphenidate and aminophylline in weaning from mechanical ventilation in patients with acute traumatic brain injury.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
GCS less than 10
Intubated
Age between 16 and 50 years
Both genders
History of acute traumatic brain injury
Absence of space-occupying lesion in brain CT scan (chronic hematoma, tumor)
Absence of seizure history
No addiction to psychoactive substances and narcotics
No history of amphetamine use
No history of hypertension, ischemic heart disease, diabetes mellitus, and liver and kidney disease
Heart rate less than 120 times per minute
Absence of sepsis or infection in any part of the body
Exclusion criteria:
Convulsions
Arrhythmia
Evidence of drug sensitivity
Death
Lack of consent of the patient to participate in the study
Age
From 16 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
189
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into 3 groups by block randomization method (block size 6). The random sequence will be performed by an epidemiologist using the online program at https://www.sealedenvelope.com/. Random chain concealment. It is done by the method of opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the double-blindness of the study, in this study the patients, as well as the person and the project partner who is responsible for completing the questionnaires and data collection, and the person analyzing the data will be unaware of the division of patients into three groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Province
Markazi
Postal code
646
Approval date
2024-06-02, 1403/03/13
Ethics committee reference number
IR.ARAKMU.REC.1403.096
Health conditions studied
1
Description of health condition studied
Acute traumatic brain injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The time required to weaning patients from the ventilator, GCS on consecutive days 1 to 9 (odd days) and check the severity of the disease based on the Apachi II criteria on consecutive days 1 to 9 (odd days) .
Timepoint
Consecutive days from 1 to 9 (odd days)
Method of measurement
The criteria for Weaning the patient from the ventilator is based on the completion of the isolation criteria questionnaire, and the evaluation of GCS and Apachi II criteria is also based on the completion of the questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Modafinil
Category
Treatment - Drugs
2
Description
Intervention group: Methylphenidate
Category
Treatment - Drugs
3
Description
Intervention group: Aminophylline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Hesameddin Modir
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak.
City
Arak
Province
Markazi
Postal code
646
Phone
+98 86 3313 6055
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Davood Hekmatpou
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran.
City
Arak
Province
Markazi
Postal code
646
Phone
+98 86 3313 6055
Email
modir.he@gmail.com
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
Hesameddin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 7,moharek pour Ave.,Alamalhoda St., Arak
City
Arak
Province
Markazi
Postal code
3819699155
Phone
+98 86 3313 9680
Email
he_modir@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hesameddin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 7.,Moharekpour Ave.,Alamalhoda St., ARAK
City
Arak
Province
Markazi
Postal code
3819699155
Phone
+98 86 3313 9680
Email
modir.he@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hesameddin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 7.,Moharekpour Ave.,Alamalhoda St., ARAK
City
Arak
Province
Markazi
Postal code
3819699155
Phone
+98 86 3313 9680
Email
he_modir@arakmu.ac.ir
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