Electroconvulsive therapy is noninvasive electrical stimulation of the brain which is resistant in the gold standard treatment for some psychiatric disorders such as MDD. Etomidate and Thiopental are such Intravenous anesthetic which are being used in this method. Choosing appropriate medicine is consider as a very important issue because of its effects on treatment duration , Seizure control , hemodynamic stability and reducing the recovery period. The objective of this survey is to compare the variation of heart rate and blood pressure, blood oxygenation, febrile convulsion, seizure induction and also recovery condition during and after electroconvulsive therapy. Also we want to investigate about the effects of electroconvulsive therapy on eliminating or reducing the Intensity of pain injection, headache, coughing, muscle aches, nausea, vomiting, myoclonus and laryngospasm during recovery after using thiopental and etomidate and Compare these two cure with together in AlZahra hospital. Research sample of this survey are referred patients of AlZahra psychiatric department to the ward at electric shock room . This study will be a randomized clinical trial without group controlling. Patients were divided into two same groups including 32 individuals by difference that we used Thiopental medicine in ones and Etomidate in the others.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092826950N2
Registration date:2016-10-31, 1395/08/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Isfahan University of Medical Sciences
Expected recruitment start date
2016-10-11, 1395/07/20
Expected recruitment end date
2017-03-10, 1395/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of recovery time and complications during the use of Etomidate and Thiopental in children under the ECT
Public title
The effect of the two drugs( Sodium Thiopental or Etomidate) duration and after ECT
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for the study : All candidates receive Electroconvulsive therapy seizures , of both sexes , age under 18 years , physical status class (ASAI) ; criteria of inclusion: Addiction to alcohol and drugs , age 5 years and older than 18 years , the physical condition of class II patients (AІІ) above , a history of seizures or epilepsy , brain injury or tumor exclusion criteria : cardio respiratory arrest , requiring intubation and cardiopulmonary resuscitation needs
Age
From 5 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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 Isfahan University of Medical Sciences
Street address
Vice Chancellor for Research, Building4, Isfahan University Of Medical Sciences, Hezarjirib St.
City
Isfahan
Postal code
7346181746
Approval date
2016-09-05, 1395/06/15
Ethics committee reference number
IR.MUI.REC.3.426
Health conditions studied
1
Description of health condition studied
Sodium Thiopental
ICD-10 code
T41.1
ICD-10 code description
Poisoning:Intravenous anaesthetics
2
Description of health condition studied
Etomidate
ICD-10 code
T41.2
ICD-10 code description
Other and unspecified general anaesthetics
Primary outcomes
1
Description
Blood Pressure
Timepoint
Before injection At 1, 5 and 10 after the shock between the two
Method of measurement
mmhg with Manometer
2
Description
Pulse
Timepoint
Before injection At 1, 5 and 10 after the shock between the two
Method of measurement
Beat per minute with Pulse Oximeter
3
Description
O2 saturation
Timepoint
Before injection At 1, 5 and 10 after the shock between the two
Method of measurement
Percent with Pulse Oximeter
4
Description
Recovery Duration
Timepoint
From the end of seizure to full consciousness
Method of measurement
Minute with Timer
5
Description
Seizure Duration
Timepoint
From the start to the end of seizure
Method of measurement
Second with Timer
6
Description
Back to Breathe Spontaneously
Timepoint
From the end of seizure to respiration
Method of measurement
Second with Timer
Secondary outcomes
1
Description
Headache
Timepoint
After recovery
Method of measurement
Ask the patient
2
Description
Cough
Timepoint
After recovery
Method of measurement
Ask the patient
3
Description
Laryngospasm
Timepoint
After recovery
Method of measurement
Evaluation of patient such as breathing and o2 sat
4
Description
Nausea and Vomiting
Timepoint
After recovery
Method of measurement
Ask the patient
5
Description
Muscle Pain
Timepoint
After recovery
Method of measurement
Ask the patient
6
Description
Pain at injection site
Timepoint
During injection
Method of measurement
Ask the patient
7
Description
Myoclonus
Timepoint
From the time of injection until after seizure
Method of measurement
Observation of Complication
Intervention groups
1
Description
First group received A packages included Succinylcholine (0.5 mg/kg) and Sodium thiopental (2 mg/kg). Drugs inject IV and bolusly.
Category
Treatment - Drugs
2
Description
Second group received B packages included Succinylcholine (0.5 mg/kg) and Etomidate (0.1mg/kg). Drugs inject IV and bolusly
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Psychiatric Ward of Medical Center Al-Zahra
Full name of responsible person
Dr. Behzad Nazemroaya
Street address
Medical Center Al-Zahra, Blvd Sofeh, Shahid Keshvari Highway, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Isfahan University Of Medical Sciences
Full name of responsible person
Research Vice Chancellor
Street address
Vice Chancellor for Research, Building4, Isfahan University Of Medical Sciences, Hezarjirib St. Isfahan
City
Isfahan
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 of Isfahan 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
Children Psychiatric Ward of Medical Center Al-Zahra
Full name of responsible person
Dr. Behzad Nazemroaya
Position
Assistant Professor/Faculty
Other areas of specialty/work
Street address
Medical Center Al-Zahra, Blvd Sofeh, Shahid Keshvari Highway
City
Isfahan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
behzad_nazem@med.mui.ac.ir
Web page address
alzahra@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology
Full name of responsible person
Dr. Behzad Nazemroaya
Position
Assistant Professor/ Faculty
Other areas of specialty/work
Street address
Department of Anesthesiology, AL-Zahra Hospital
City
Isfahan
Postal code
Phone
+98 31 3620 2020
Fax
Email
behzad_nazem@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Anesthesiology
Full name of responsible person
Dr. Behzad Nazemroaya
Position
Assistant Professor/Faculty
Other areas of specialty/work
Street address
Department of Anesthesiology, Al-Zahra Hospital
City
Isfahan
Postal code
Phone
+98 31 3620 2020
Fax
Email
behzad_nazem@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)