Protocol summary

Summary
The aim of this study is to compare the effects of propofol and etomidate as induction agents for electroconvulsive therapy on rate pressure product and oxygen saturation. Having severe depression and resistance to medication are main inclusion criteria. Patients with cardiovascular disease, hypertension, and brain lesions are to be excluded from the study. In this double-blind study 60 patients who meet inclusion and exclusion criteria will be randomly assigned into two equal groups to receive either propofol or etomidate as induction agent for electroconvulsive therapy. Patients in the propofol group will be received 0.5-1 mg / Kg of propofol and succinylcholine 0.34-0.4 mg / Kg and patients in etomidate group will be received etomidate 0.3 mg / Kg and same dose of succinylcholine intravenously. Then electrical stimulation is given. Systolic and diastolic blood pressure, pulse rate and oxygen saturation of the patients in both groups before and 1 min after induction and at 1, 3 and 5 minutes after the electrical stimulation will be recorded. Finally, oxygen saturation and rate pressure product in two groups will be compared and evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013081214138N2
Registration date: 2013-09-28, 1392/07/06
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-09-28, 1392/07/06
Registrant information
Name
Mehrdad Mahdian
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1562 0634
Email address
mahdian_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-10-07, 1392/07/15
Expected recruitment end date
2014-05-05, 1393/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of propofol and etomidate on rate pressure product and oxygen saturation in patients undergoing electroconvulsive therapy
Public title
Comparison of effects of propofol and etomidate on cardiac and respiratory parameters during electroconvulsive therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients who are candidates of electroconvulsive therapy and have following criteria: severe depression, acute mania, catatonia, cases who need immediate treatment and patients who do not respond to medications. Exclusion criteria: Ischemic heart disease, Hypertension, dysrhythmia, brain lesions.
Age
No age limit
Gender
Both
Phase
N/A
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
Kashan University of Medical Sciences
Street address
Qutb-e ravandi Blvd
City
Kashan
Postal code
8719674591
Approval date
2012-08-08, 1391/05/18
Ethics committee reference number
29/5/1/1915/پ

Health conditions studied

1

Description of health condition studied
Severe depression
ICD-10 code
F32.2 and
ICD-10 code description
Severe depressive episode without psychotic symptoms and Severe depressive episode with psychotic symptoms

Primary outcomes

1

Description
Rate Pressure Product(systolic blood pressure multiplied pulse rate)
Timepoint
Before and 1 min after induction, 1, 3 and 5 min after ECT
Method of measurement
Blood pressure will be measured by sphygmomanometer in mmHg and pulse rate through pulseoximeter

2

Description
Blood oxygen saturation,(SPO2)
Timepoint
Before and 1 min after induction, 1, 3 and 5 min after ECT
Method of measurement
Through pulseoximeter as real numbers

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: Patients will be received etomidate 0.3 mg / Kg and succinylcholine 0.34-0.4 mg / Kg for induction of anesthesia for ECT.
Category
Treatment - Drugs

2

Description
Control: Patients will be received 0.5-1 mg / Kg of propofol and succinylcholine 0.34-0.4 mg / Kg for anesthesia induction for ECT.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan University of Medical Sciences, Shahid Beheshti hospital
Full name of responsible person
Mehrdad Mhdian
Street address
Qutb-e Ravandi Blvd.
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences, Deputy of Research
Full name of responsible person
Gholam Ali Hamidi
Street address
Qutb-e ravandi Blvd.
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences, Deputy of Research
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
Kashan University of Medical Sciences
Full name of responsible person
Mehrdad Mahdian
Position
Faculty member/ MSc (Anesthesia)
Other areas of specialty/work
Street address
Ghotb-e ravandi Blvd.
City
Kashan
Postal code
87196-74591
Phone
+98 36 1562 0634
Fax
+98 36 1562 0634
Email
mahdian_m@kaums.ac.irmmahdian78@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehrdad Mahdian
Position
Faculty member/ Msc (Anesthesia)
Other areas of specialty/work
Street address
Ghotb-e ravandi Blvd
City
Kashan
Postal code
87196-74591
Phone
+98 36 1562 0634
Fax
+98 36 1562 0634
Email
mahdian_m@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehrdad Mahdian
Position
faculty member/ MSc (Anesthesia)
Other areas of specialty/work
Street address
Qutb-e ravandi Blvd.
City
Kashan
Postal code
87196-74591
Phone
+98 36 1562 0634
Fax
+98 36 1562 0634
Email
mahdian_m@kaums.ac.irmmahdian78@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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