the purpose of this study is Comparison of anesthesia with ketamine or thiopental during electro-shock in patients with treatment-resistant major depression. This study will be done on patients with treatment-resistant major depression, 20 to 50 years without any physical illness such as cardiovascular, cerebrovascular, high intracranial pressure, glaucoma, high eyes pressure, uncontrolled high blood pressure. 160 patients admitted to Amir Kabir hospital psychiatric department will be divided into two groups. The first group will be anesthetized with ketamine for ECT and The second group with thiopental. After electroshock and recovery from anesthesia, complications will be checked and recorded for an hour.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015013012642N13
Registration date:2015-02-20, 1393/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-20, 1393/12/01
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research of Arak University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of anesthesia with ketamine or thiopental during electro-shock in patients with treatment-resistant major depression
Public title
The effect of anesthetic agents on electroshock In patients with treatment-resistant major depression
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: age between 20 to50 years old; refractory depression According to the psychiatrist diagnosis.
exclusion criteria: Any physical illness such as cardiovascular-cerebrovascular disease; high intracranial pressure; glaucoma; high eyes pressure; uncontrolled high blood pressure; Arterial Aneurysm; Previous history of alcohol and drug use; The occurrence of myocardial infarction in the last three months; Failure to ECT in the past month
Age
From 20 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Arak University of Medical Sciences
Street address
Ethical committee of Research of Arak University of Medical Sciences, Sardasht Square,
City
Arak
Postal code
Approval date
2013-06-01, 1392/03/11
Ethics committee reference number
92-146-3
Health conditions studied
1
Description of health condition studied
Treatment-resistant depression
ICD-10 code
F32.3
ICD-10 code description
Severe depressive episode with psychotic symptoms
Primary outcomes
1
Description
depression
Timepoint
After completion of each stage of the ECT and Gained consciousness
Method of measurement
evaluation is based on the Hamilton test Depression
2
Description
seizure time
Timepoint
After completion of each stage of the ECT and Gained consciousness
Method of measurement
According to an electrical timer in seconds
Secondary outcomes
1
Description
Herat rate
Timepoint
After completion of each stage of the ECT and the conscious patient
Method of measurement
By pulse oximetry in terms of the number of minutes
2
Description
blood pressure
Timepoint
After completion of each stage of the ECT and the conscious patient
Method of measurement
Manometer gauge in mmHg
Intervention groups
1
Description
first group: treatment-resistant depressed patients are anesthesied with ketamine with dose of 0.8 mg per killogeram was used in Ect.
Category
Prevention
2
Description
second group: treatment-resistant depressed patients are anesthesied with thiopental with dose of 1.5 mg per killogeram was used in Ect.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Amir Kabir Hospital
Full name of responsible person
Majid Golestani Eraghi
Street address
Parastar square, Shahid Shiroodi Ave
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research of Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafee
Street address
Vice Chancellor of Research of Arak University of Medical Sciences, Sardasht Square, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research of Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology, Tehran University of Medical Sciences
Full name of responsible person
Esmaeil Moshiri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr Square
City
Arak
Postal code
Phone
+98 86 3222 2003
Fax
Email
dr.moshiri@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesia group, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship specialtyanesthesia and intensive care
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
dr.golestani@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)