Comparison of the effects of Ketamine and Propofol and Dexmedetomidine in treatment with electroconvulsive therapy in patients with resistant to treatment major depressive disorder
Comparison of the effects of Ketamine and Propofol and Dexmedetomidine in treatment with electroconvulsive therapy in patients with resistant to treatment major depressive disorder
Design
This double-blind and clinical trial .68 Patient candidate with resistant major depression requires electroshock in psychiatric department of Amirkabir Hospital of Arak. We will divide patients in 4 groups by simple randomization. Groups are parallel.
Settings and conduct
This double-blind and clinical trial .68 Patient candidate with resistant major depression requires electroshock in the psychic section in Amirkabir Hospital of Arak. We will divide patients in 4 groups by simple randomization. The study is double-blind.Outcome elevator and analyzer and participant are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18 to 60 years, both sexes, patients with a diagnosis of schizophrenia
Exclusion criteria:no history of drug use, no pregnancy, no history of cardiovascular disease , do not take beta-blockers, lack of sensitivity to the drugs used in this study, there are no contraindications to ECT, such as spinal cord injury and high ICP, and recent heart attacks
Intervention groups
Intervention group: We inject 0.2 micro grams per kilogram Dexmedetomidine in 10 millilitre normal saline for 10 minute slowly.
Intervention group: We inject 1/5 milligram per kilogram Propofol in 10 millilitre normal saline for 10 minute slowly.
Intervention group: We inject 0/8 milligram per kilogram Ketamin in 10 millilitre normal saline for 10 minute.
Control group: We inject 10 millilitre normal saline as placebo for 10 minute.
Comparison of the effects of Ketamine and Propofol and Dexmedetomidine in treatment with electroconvulsive therapy in patients with resistant to treatment major depressive disorder
Public title
Comparison of the effects of Ketamine and Propofol and Dexmedetomidine in treatment with electroconvulsive therapy in patients with depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 60 years
Both sexes
Patients with a diagnosis of schizophrenia
Exclusion criteria:
No history of drug use
No pregnancy
No history of cardiovascular disease (arrhythmias, ischemia, heart block)
Do not take beta-blockers
There are no contraindications to ECT, such as spinal cord injury and high ICP, and recent heart attacks.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in 4 groups A and B and C and D .
In this method, we write a few cards or letters as intervention groups and the same number of cards for the control group, then the cards are mixed. One card is taken out and its allocation is registered and the card is returned to the other cards after leaving. Then the cards are mixed again and then another card is picked up. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind).Outcome elevator and analyzer and participant don't aware from grouping.
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
2020-01-18, 1398/10/28
Ethics committee reference number
IR.ARAKMU.REC.1398.290
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Heart rate
Timepoint
Every 5 minutes
Method of measurement
Counting
2
Description
Mean blood pressure
Timepoint
Every 5 minutes
Method of measurement
Barometer
3
Description
Seizure duration
Timepoint
In times of seizures
Method of measurement
Minutes
4
Description
Patient satisfaction
Timepoint
After the shock
Method of measurement
Satisfaction Questionnaire
5
Description
Recovery duration
Timepoint
After the shock
Method of measurement
Minute
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: We inject 0.2 micro grams per kilogram Dexmedetomidine (Prizer-America) in 10 millilitre normal saline for 10 minute slowly.
Category
Treatment - Drugs
2
Description
Intervention group 2: We inject 1.5 milligram per kilogram Propofol(Tehran shimi-Iran) in 10 millilitre normal saline for 10 minute slowly.
Category
Treatment - Drugs
3
Description
Intervention group 3: We inject 0.8 milligram per kilogram Ketamin (ROTEXMEDICA -Germany) in 10 millilitre normal saline for 10 minute.
Category
Treatment - Drugs
4
Description
Control group: We inject 10 millilitre normal saline as placebo for 10 minute.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Amirkabir hospital, Parastar square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
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 Alireza Kamali
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
alikamaliir@yahoo.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
Dr Behnam Mahmodie
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 86 3222 2003
Email
mahmodie@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street