After obtaining written informed consent from eligible patients, and getting an approval from Ethics committee of Ahvaz Jundishapur University of Medical Sciences, a double-blind prospective, randomized study will be done to Evaluation the effect of Propofol, Etomidate and Sodium Thiopental on depth of Anesthesia and duration of Seizure in the patient treated by Electroconvulsive Therapy(ECT). Inclusion criteria: Admitted patients for Electroconvulsive therapy in Golestan hospital; 30 to 50 years old; Anesthesia risk of 1, 2 (According to American society of anesthesiologist's classification). Exclusion criteria: Patient refuse; under 30 and over 50 years old; A history of drug abuse; Sensitivity to egg; Contraindication of Propofol, Etomidate or Sodium Thiopental. Patients will be randomly allocated into three groups according to table of random numbers. Groups "one", "two", and "three" will receive intravenous Propofol 2 mg/kg, Etomidate 0.4 mg/kg, and Sodium Thiopental 5 mg/kg, respectively. Depth of Anesthesia Continuously during procedure will be evaluated by BIS monitoring according to numbers from 0 to 100. Duration of Seizure according to clinical observation and awakening and discharge from recovery according to Aldrete Score after procedure will measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050617602N1
Registration date:2014-05-20, 1393/02/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-20, 1393/02/30
Registrant information
Name
Zohre Fadaei
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 1358 9698
Email address
fadaei.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2015-02-04, 1393/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Propofol, Etomidate, and Sodium Thiopental on depth of Anesthesia and duration of Seizure in the electroconvulsive therapy
Public title
Evaluation the effect of Propofol, Etomidate, and Sodium Thiopental on depth of Anesthesia and duration of Seizure in the electroconvulsive therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Admitted patients for Electroconvulsive Therapy in Golestan hospital;
30 to 50 years old;
Anesthesia risk of 1, 2 (According to American society of anesthesiologist's classification).
Exclusion criteria:
Patient refuse;
Under 30 and over 50 years old;
A history of drug abuse;
Sensitivity to egg;
Contraindication of Propofol, Etomidate or Sodium Thiopental.
Age
From 30 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
132
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
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No. 21, Ave. 1, Golestan Blvd.
City
Ahvaz
Postal code
Approval date
2014-01-11, 1392/10/21
Ethics committee reference number
Ajums.REC.1392.317
Health conditions studied
1
Description of health condition studied
Electroconvulsive Therapy
ICD-10 code
F32
ICD-10 code description
Treatment of depressive episode
Primary outcomes
1
Description
Measuring Depth of Anesthesia
Timepoint
Continuously during procedure
Method of measurement
By bipolar electroencephalographic leads that connected to the temporal and frontal area of patients and brain waves evaluated by BIS monitoring according to numbers from 0 to 100.
2
Description
Duration of Seizure
Timepoint
After procedure
Method of measurement
Clinical Observation
Secondary outcomes
empty
Intervention groups
1
Description
Propofol:
Dose: 2 mg/kg
Number of using: Once
Factory name: Astra Zeneca
Manufacturing Country's Name: India
Location prescribed: Intravascular
Administration time: At the beginning of the procedure
Category
Treatment - Drugs
2
Description
Etomidate:
Dose: 0.4 mg/kg
Number of using: Once
Factory name: Janssen Cilag
Manufacturing Country's name: England
Location prescribed: Intravascular
Administration time: At the beginning of the procedure
Category
Treatment - Drugs
3
Description
Sodium Thiopental:
- Dose: 5 mg/kg
- Number of using: Once
- Factory name: Jubilant
- Manufacturing Country's name: India
- Location prescribed: Intravascular
- Administration time: At the beginning of the procedure