Comparison effect of addition Dexmedetomidine and Metoprolol to Tiopntal on hydrodynamic responses, agitation and patients satisfaction in electro convulsive therapy for patients with mood disorder
Aim of this study is comparison effect of addition Dexmedetomidine and Metoprolol to Tiopntal on hydrodynamic responses, agitation and patients satisfaction in electro convulsive therapy for patients with mood disorder
Design
Patients with mood disorder candidate ECT referring Amirkabir hospital.This study is clinicqal trial and double blind.48 patients is in this study.
Settings and conduct
Patients with mood disorder candidate ECT referring Amirkabir hospital.This study is clinicqal trial and double blind.48 patients is in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients with cognitive dysfunction receive ECT, 18 to 60 years
Exclusion criteria:All patients with anesthesia induced cardiac arrest during ECT, all patients who after ECT due to long-term apnea and respiratory distress need to intubation, all patients who don't have seizures during the ECT process.
Intervention groups
We inject 0/5 micro gram in kilogram Dexmedetomidin before intubation in first group and we inject 2/5 milligram Metoral 10 minute before intubation.
Main outcome variables
Mean of blood pressure, Heart rate, degree of restlessness,degree of satisfaction, duration of seizure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N87
Registration date:2018-10-31, 1397/08/09
Registration timing:registered_while_recruiting
Last update:2018-10-31, 1397/08/09
Update count:0
Registration date
2018-10-31, 1397/08/09
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
2018-05-20, 1397/02/30
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of addition Dexmedetomidine and Metoprolol to Tiopntal on hydrodynamic responses, agitation and patients satisfaction in electro convulsive therapy for patients with mood disorder
Public title
Comparison effect of addition Dexmedetomidine and Metoprolol to Tiopntal on hydrodynamic responses, agitation and patients satisfaction in electro convulsive therapy for patients with mood disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with cognitive dysfunction receive ECT
18 to 60 years
Exclusion criteria:
All patients with anesthesia induced cardiac arrest during ECT
All patients who after ECT due to long-term apnea and respiratory distress need to intubation.
All patients who don't have seizures during the ECT process.
Age
From 18 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:
48
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
2018-05-13, 1397/02/23
Ethics committee reference number
IR.ARAKMU.REC.1397.044
Health conditions studied
1
Description of health condition studied
Mood disorder
ICD-10 code
F06.3
ICD-10 code description
Mood disorder due to known physiological condition
Primary outcomes
1
Description
Mean of blood pressure
Timepoint
Before and after electro convulsive therapy
Method of measurement
Barometer
2
Description
Heart rate
Timepoint
Before and after electro convulsive therapy
Method of measurement
count
3
Description
Degree of restlessness
Timepoint
After electro convulsive therapy
Method of measurement
Agitation score
4
Description
Degree of satisfaction
Timepoint
After electro convulsive therapy
Method of measurement
satisfaction score
5
Description
Duration of seizure
Timepoint
After electro convulsive therapy
Method of measurement
Minute
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We inject 0/5 micro gram in kilogram Dexmedetomidin before intubation in first group.
Category
Treatment - Drugs
2
Description
Intervention group: We inject 2/5 milligram Metoral 10 minute before intubation.
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
Research Center, Payambar Azam complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Email
m.arjmandzadegan@arak.mu.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
Assistant 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 Hamidreza Jamilian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amirkabir hospital, Parastar square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
Jamilian@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Talat Mohammadi
Position
Resident of psychology
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Email
t.mohammadi81@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 Hamidreza Jamilian
What processes are involved for a request to access data/document
They have to write letters to the professors and the university