While the therapeutic effects of electroconvulsive therapy (ECT) on major depressive disorder is widely investigated, there is a gap in literature regarding the possible effects of the medications used for induction of anesthesia in ECT. To the best of authors’ knowledge, this study is the first randomized double blind clinical trial compares the effect of etomidate and sodium thiopental on the depression symptoms in patients administered ECT.
The participants of this study are sixty adult patients with major depressive disorder who were referred for taking ECT. They were randomly allocated into one of the two groups. One group received etomidate and the other group received sodium thiopental as medication for induction of anesthesia. All the patents received similar bilateral ECT. The outcomes were Beck Depression Inventory (BDI) score, seizure duration, and recovery duration after induction of anesthesia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104123468N6
Registration date:2011-04-27, 1390/02/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-27, 1390/02/07
Registrant information
Name
Mohammad Reza Hajiesmaeili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00983516227747-00983517232422
Email address
hajiesmaeili@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research,Shahid Sadoughi University of medical science and health services, Yazd, Iran.
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2009-03-15, 1387/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Etomidate and Sodium Thiopental in anesthesia induction in Electroconvulsive therapy
Public title
Anesthesia induction in Electroconvulsive therapy for major depressive disorder
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria:
Adult major depressive psychiatric patients 18-50 years
ASA=I,II, referred by psychiatrist to take ECT
exclusion criteria:
discontinue study protocole
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Shahid Sadoughi University of Medical Sciences and health services
Street address
deputy of research- shahid bahonar square-yazd-iran
City
Yazd
Postal code
Approval date
2008-11-21, 1387/09/01
Ethics committee reference number
1738
Health conditions studied
1
Description of health condition studied
Recurrent depressive disorder
ICD-10 code
F33
ICD-10 code description
Recurrent depressive disorder
Primary outcomes
1
Description
Depression
Timepoint
after 6 sessions of ECT
Method of measurement
Beck Depression Inventory (BDI) score
Secondary outcomes
1
Description
seizure duration
Timepoint
each session
Method of measurement
second
2
Description
Recovery duration
Timepoint
each session
Method of measurement
minute
3
Description
side effects
Timepoint
each session
Method of measurement
observation
Intervention groups
1
Description
A group received intravenous sodium thiopental (2.5%, 3mg/kg) . All the patients in both groups received 6 sessions similar bitemporal ECT.
Category
Treatment - Other
2
Description
in second group, patients received 0/2 mg/kg etomidate for anesthesia induction and they received ECT for 6 sessions.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry Hospital
Full name of responsible person
Ghasem Dastgerdi
Street address
Psychiatry Hospital
City
Taft
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Hassan Mozaffari Khosravi
Street address
Shahid Sadoughi University of Medical Sciences
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mohammad Hassan Abdollahi
Position
assistant professor of anesthesiology
Other areas of specialty/work
Street address
Afshar Hospital- Yazd- Iran
City
Yazd
Postal code
Phone
+98 35 1525 6012
Fax
Email
mhabdollahi@yahoo.co.uk
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Department of Psychiatry, Hafez Hospital, Sh
Full name of responsible person
Ahmad Ghanizadeh
Position
associated professor
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
Phone
+98 71 1627 9319
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mohammad Reza Haji Esmaeili
Position
Anesthesiologist
Other areas of specialty/work
Street address
Rahnemoon Hospital
City
Yazd
Postal code
Phone
+98 35 1622 7747
Fax
Email
hajiesmaeili@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)