40 patients with major depression candidate of electroconvulsive therapy (ECT) will be included. For induction of anesthesia the first group (20 patients) receives sodium thiopental in the first ECT session and ketamin in the second session. In another 20 patients the sequence of anesthetic medications would be vice versa. Hemodynamic measurements including blood pressure and heart rate will be recorded before induction, and 1,2,4 and 10 minutes after ECT. The duration of seizure will be recorded, as well.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306255026N3
Registration date:2013-07-11, 1392/04/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-11, 1392/04/20
Registrant information
Name
Masood Mohseni
Name of organization / entity
Rasul Akram hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
mohseni@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research budjet of Tehran University of Medical Sciences
Expected recruitment start date
2013-06-26, 1392/04/05
Expected recruitment end date
2014-06-26, 1393/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Ketamin versus Thiopental sodium on hemodynamic profile and seizure duration in ECT patients
Public title
The effect of anesthetic medications on the quality of electrocunvulsive therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Major depression candidate for electroconvulsive therapy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blv
City
Tehran
Postal code
Approval date
2013-04-19, 1392/01/30
Ethics committee reference number
20385
Health conditions studied
1
Description of health condition studied
Major depression without psychotic feature
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
2
Description of health condition studied
Major depression with psychotic feature
ICD-10 code
ّّ32.3
ICD-10 code description
Severe depressive episode with psychotic symptoms
Primary outcomes
1
Description
Heart rate
Timepoint
before induction, 1, 3 and 10 minutes after induction
Method of measurement
ECG monitoring
2
Description
Blood pressure
Timepoint
before induction, 1, 3 and 10 minutes after induction
Method of measurement
mm Hg using noninvasive blood pressure monitoring
3
Description
duration of seizure
Timepoint
after termination of seizure
Method of measurement
Chronometer
Secondary outcomes
1
Description
Nausea
Timepoint
discharge from recovery
Method of measurement
direct question from patients and recording in data collection form
Intervention groups
1
Description
ketamin 0.3 mg/kg for induction of anesthesia
Category
Treatment - Drugs
2
Description
Sodium Thiopental 0.2 mg/kg for induction of anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Meidcal center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tehran university of Medical Sciences
Full name of responsible person
Akbar Fotuhi
Street address
6th floor, Tehran University of medical sciences, Ghods Ave., Keshavarz Blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Assistant professor of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Rasoul Akram Medical Center, Sattarkhan St
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
m-mohseni@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Assistant professor of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Rasoul Akram Medical Center, Sattarkhan St
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
m-mohseni@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Assistant professor of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Rasoul Akram Medical Center, Sattarkhan St
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)