Investigating the effect of methylphenidate on increasing the level of consciousness of patients with hypoxic ischemic encephalopathy in the special care departments of Bo Ali Qazvin Hospital during one year.
Investigating the effect of methylphenidate on increasing the level of consciousness of patients suffering from hypoxic ischemic encephalopathy
Design
A clinical trial with a control group, with parallel groups, double-blind, using placebo, randomized, phase 3 on 29 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Patients with hypoxic-ischemic encephalopathy in Bu-Ali hospital in Qazvin were included in the study by available sampling method, then the patients were blocked using random sampling method and assigned to one of the two study groups. In one group, methylphenidate 10 mg were given once a day and were combined with standard treatment, and the other group received only standard treatment. The level of consciousness in the patients was measured by the Four Score method and the vital signs in the patients of both groups were measured and its number was noted along with the hemodynamic indicators every three days during the patient hospitalization in the ICU .
Participants/Inclusion and exclusion criteria
Patients hospitalized in ICU; with the diagnosis of HIE; aged between 18 and 65 years; both sexes; with some degree of reduced level of consciousness.
Intervention groups
The first study group was given methylphenidate tablets 10 mg once a day in the morning until the day the patient stayed in the ICU (maximum one month) and the second study group was not given methylphenidate tablets.
Main outcome variables
Level of consciousness, duration of hospitalization in ICU.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220924056025N1
Registration date:2022-10-09, 1401/07/17
Registration timing:prospective
Last update:2022-10-09, 1401/07/17
Update count:0
Registration date
2022-10-09, 1401/07/17
Registrant information
Name
Kian Abed khorasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3350 4270
Email address
kianabed2495@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of methylphenidate on increasing the level of consciousness of patients with hypoxic ischemic encephalopathy in the special care departments of Bo Ali Qazvin Hospital during one year.
Public title
Investigating the effect of methylphenidate on increasing the level of consciousness in patients with hypoxic ischemic encephalopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients hospitalized in the intensive care unit with the diagnosis of HIE hypoxic ischemic encephalopathy,
Aged between 18 and 65 years
Both sexes (male and female)
With some degree of reduced level of consciousness.
Exclusion criteria:
Patients with a history of epilepsy
Patients with high blood pressure that is newly discovered and not treated or controlled
Patients with Cardiac ischemia and arrhythmia that are newly discovered and not treated or controlled,
Patients with deafness
Patients with rapid changes in vital signs and unstable hemodynamics
Patients with multiple organ failure
Patients with hyperthyroidism
pregnancy
Drug addiction
Secondary surgery
Reluctance to attend the investigation based on the opinion of the patient's legal guardian
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected and included in the study using the available sampling method based on the entry and exit criteria. To assign patients to treatment groups, block randomization method is used so that the number of samples assigned to each of the two treatment groups is balanced. According to the sample size of 24 in each group, 12 blocks of 4 random permutations of two treatment methods A, B (in the form of AABB) are needed. Random allocation software version 2 is used to create random permutations of 4 (random blocks of 4). The output of the software is alternating random combinations of 4 of the two treatment methods, based on which the patients are assigned to one of the two treatment groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
A placebo is prepared by a pharmaceutical company similar to methylphenidate tablets at the request of the researcher. After that, the placebo and the drug are coded by a non-researcher observer, and the coded drugs are provided to the researcher. The drug code is provided to the researcher at the end of the study. . the standard treatment, while the patient nurse researcher does not know which group the patient is in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Qazvin University of Medical Science
Street address
No115,East406,Phase 4 Mehrshahr ,Karaj
City
Qazvin
Province
Qazvin
Postal code
3183834377
Approval date
2020-09-18, 1399/06/28
Ethics committee reference number
IR.QUMS.REC.1399.226
Health conditions studied
1
Description of health condition studied
Hypoxic ischemic encephalopathy
ICD-10 code
P91.6
ICD-10 code description
Hypoxic ischemic encephalopathy [HIE]
Primary outcomes
1
Description
Average level of consciousness based on 4 Score criteria
Timepoint
Every three days for a month
Method of measurement
Criterion 4 Score in ICU
Secondary outcomes
1
Description
Average biological indicators of systole and diastole blood pressure
Timepoint
Every three days for a maximum of one month
Method of measurement
Recording of ICU patient monitoring every three days for a maximum of one month
2
Description
Average biological index of arterial oxygen saturation percentage
Timepoint
Every three days for a maximum of one month
Method of measurement
Recording of ICU patient monitoring every three days for a maximum of one month
3
Description
Average biological index of heart rate
Timepoint
Every three days for a maximum of one month
Method of measurement
Recording of ICU patient monitoring every three days for a maximum of one month
Intervention groups
1
Description
Intervention group: this group receives 10 mg methylphenidate tablets once a day in the morning until the day the patient stays in the ICU (maximum one month) in the form of gavage.
Category
Treatment - Other
2
Description
Control group: The control group receives daily placebo in the form of gavage in the morning until the day the patient stays in the ICU (maximum one month).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali Qazvin Hospital ,ICU Dep
Full name of responsible person
Kian Abed Khorasani
Street address
Naderi st, Bo Ali Hospital,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
Kianabed2495@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin Medical Sciences Research Deputy
Full name of responsible person
Dr. Mehdi Mir Hashemi
Street address
Qazvin, Bahonar Ave, Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Fax
+98 28 3333 6002
Email
kianabed2495@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin Medical Sciences Research Deputy
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
Qazvin University of Medical Sciences
Full name of responsible person
Kian Abed Khorasani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 115, Golha Blvd. 406 East, Karaj Phase Four, Mehr City
City
Qavzin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
kianabed2495@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Kian Abed Khorasani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 115, Golha Blvd. 406 East, Karaj Phase Four, Mehr City
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 2930
Email
kianbed2495@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Kian Abed Khorasani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 115, Golha Blvd. 406 East, Karaj Phase Four, Mehr City
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
kianabed2495@gmail.com
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
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data in accordance with the approval of the ethics committee
Primary and secondary outcomes
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Physicains working in the special care department of hospitals
Under which criteria data/document could be used
Contact to the researcher for determining the examples
From where data/document is obtainable
Dr. Kian Abed Khorasani, Qazvin University of Medical Sciences, contact number 09907485823, email
kianabed2495@gmail.com
What processes are involved for a request to access data/document
Direct contact with the researcher, investigation and response within a maximum of two weeks, in case of non-availability, contact with the Research Vice-Chancellor of Qazvin University of Medical Sciences