Aim of this study was comparison of premedication Dexmedetomidine and Remifentanil and Labetalol before ECT on hemodynamic responses and seizure time in patients
Design
144 patients candidate electroshock will inter this study.This study is clinical trial and double blind.We will divide patients in 3 groups.
Settings and conduct
144 patients candidate electroshock will inter this study.This study is clinical trial and double blind. This study is double blind.Outcome elevator and analyzer are blind (double blind).Outcome elevator and analyzer don't aware from grouping
Participants/Inclusion and exclusion criteria
Inclusion criteria: 16-60 years, both of gender,no history of drug use,not pregnancy,no history of cardiovascular disease (arrhythmia, ischemia, heart block),no taking beta-blocker medication, insensitivity to the drugs used in this study, patients with schizophrenia diagnosis
Exclusion criteria:Lack of consent to cooperate, patients who require more than 60% energy for tonic clonic seizures, patients whose clonic tonic seizures are less than 25 seconds, all patients with ECT undergoing arrhythmia or hemodynamic threatening changes requiring intervention therapies.
Intervention groups
We inject 0/5 micro gram in kilogram Dexmedetomidin.
We inject 0/2 milliliter in kilogram Labtalol.
We inject 20 milliliter normal saline.
Comparison of premedication Dexmedetomidine and remifentanil and Labetalol before ECT on hemodynamic responses and seizure time in patients
Public title
Comparison of premedication Dexmedetomidine and remifentanil and Labetalol before ECT on hemodynamic responses and seizure time in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
16-60 years
both of gender
No history of drug use
Not pregnancy
No history of cardiovascular disease (arrhythmia, ischemia, heart block)
No taking beta-blocker medication
Insensitivity to the drugs used in this study
Patients with schizophrenia diagnosis
Exclusion criteria:
Lack of consent to cooperate
Patients who require more than 60% energy for tonic clonic seizures.
Patients whose clonic tonic seizures are less than 25 seconds.
All patients with ECT undergoing arrhythmia or hemodynamic threatening changes requiring intervention therapies.
Age
From 16 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind.Outcome elevator and analyzer are blind (double blind).Outcome elevator and analyzer don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2018-08-19, 1397/05/28
Ethics committee reference number
IR.ARAKMU.REC.1397.133
Health conditions studied
1
Description of health condition studied
Psychotic patients
ICD-10 code
F06.0
ICD-10 code description
Psychotic disorder with hallucinations due to known physiological condition
Primary outcomes
1
Description
blood pressure
Timepoint
Start, 1 and 5 and 10 minute before ECT and every 5 minute after ECT to transfer to hospital section
Method of measurement
Barometer
2
Description
Heart rate
Timepoint
Start, 1 and 5 and 10 minute before ECT and every 5 minute after ECT to transfer to hospital section
Method of measurement
Count
3
Description
Seizure duration
Timepoint
Duration ECT
Method of measurement
Minute
4
Description
Recovery duration
Timepoint
After ECT
Method of measurement
Minute
5
Description
satisfaction
Timepoint
After ECT
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We inject 0/5 micro gram in kilogram Dexmedetomidin
Category
Treatment - Drugs
2
Description
Intervention group: We inject 0/2 milliliter in kilogram Labtalol.
Category
Treatment - Drugs
3
Description
Control group: We inject 20 milliliter normal saline.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Hamidreza Jamilian
Street address
Amirkabir hospital, Parastar Square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
hjamilian@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
Vice Chancellor For Research, Arak University Of Medical Science
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+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 Hesamedin Modir
Position
Assistante 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 86 3222 2003
Email
modir.he@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Assistante 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 86 3222 2003
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
Sina Bahramsari
Position
Medicine student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
s.bahramsari@yahoo.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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
When we publish article in journal
When the data will become available and for how long
After the article is published
To whom data/document is available
researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Modir
What processes are involved for a request to access data/document
They have to write letters to the professors and the university