In this double blind randomized clinical trial, duration of seizure and amnesia after electroconvulsive therapy under etomidate anesthesia will be compared with routine thiopental anesthesia. Sixty consecutive male or female patients at the age of 18 to 40 years old who are candidate for ECT, assign in etomidate or thiopental group. Exclusion criteria are use of antiepileptic drugs and anesthesia complications. One days before ECT retrograde memory assessment test and anterograde memory will be performed. Before induction, 10 picture cards shown to the patient and asking them to remember them at the end of recovery. Induction of anesthesia is achieved with etomidate (0.3 mg/kg) and succinylcholine (0.5 mg/kg) in intervention group and thiopental (3mg/kg) and succinylcholine (0.5 mg/kg) in control group. Only anesthesiologist and nurse anesthesia are not blind and patient and investigators that are responsible for data collection will be masked. Measurable outcomes are duration of seizures (during anesthesia), and memory assessment at the end of recovery, 4 hours later, the next day and once a week for a month after ECT procedures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040212123N4
Registration date:2017-03-28, 1396/01/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-28, 1396/01/08
Registrant information
Name
Javad Nourian
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 27 3334 2001
Email address
javadnourian@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Shahroud University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of etomidate and thiopental on seizure duration and amnesia in electroconvulsive therapy
Public title
Comparison of etomidate anesthesia and thiopental anesthesia on duration of seizure and amnesia after electroconvulsive therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: male or female patients at the age of 18 to 40 years old who are candidate for ECT
Exclusion:patients with ASAclass3 or higher, use of antiepileptic drugs and anesthesia complications
Age
From 18 years old to 40 years old
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
Ethics committee, Deputy of Research, Shahroud University of Medical Sciences
Street address
Deputy of Research, Shahroud University of Medical Sciences
City
Shahroud
Postal code
3614773955
Approval date
2016-01-03, 1394/10/13
Ethics committee reference number
IR.SHMU.REC.1394.52
Health conditions studied
1
Description of health condition studied
psychiatric disorders
ICD-10 code
F20
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders
2
Description of health condition studied
psychiatric disorders
ICD-10 code
ّF31
ICD-10 code description
Bipolar affective disorder
Primary outcomes
1
Description
duration of seizure
Timepoint
start of tonic contractions to end of clonic contractions
Method of measurement
second ( use of chronometer)
2
Description
retrograde memory
Timepoint
One day before ECT,before induction of anesthesia, at the end of recovery, 4 hours later, the next day and once a week for a month after ECT procedures
Method of measurement
Asking 10 questions that patient can answer, like tel. number, patient's high school name or president name. These questions will repeat for detection of retrograde amnesia
3
Description
anterograde memory
Timepoint
One day before ECT, before induction of anesthesia, at the end of recovery, 4 hours later, the next day and once a week for a month after ECT procedures
Method of measurement
Showing 10 picture cards (car, house, airplane…) and then ask the patient to find them among 15 picture cards. If the patient recall all cards, he/she take 10 points.
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group induction of anesthesia achieves with etomidate (0.3 mg/kg) and succinylcholine (0.5 mg/kg), ventilation with 100% oxygen and monitoring of pulse rate, blood pressure and SPo2 will be done.
Category
Treatment - Drugs
2
Description
In control group induction of anesthesia achieves with thiopental (3mg/kg) and succinylcholine (0.5 mg/kg), ventilation with 100% oxygen and monitoring of pulse rate, blood pressure and SPo2 will be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Javad Nourian MD
Street address
Imam Hossein Hospital, Ayatollah Towhidi Avenue
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hasan Emamian
Street address
Deputy of Research, Shahroud University of Medical Sciences, 7th of Tir square
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Shahroud 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
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant professor of Anesthesiology
Other areas of specialty/work
Street address
Imam Hossein Hospital, Towhidi Avenue Shahroud
City
Shahroud
Postal code
3616911151
Phone
+98 23323342001
Fax
+98 23 3233 3902
Email
javadnourian@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Imam Hossein Hospital, Towhidi Avenue
City
Shahroud
Postal code
3616911151
Phone
+98 23 3234 2001
Fax
Email
javadnourian@shmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Imam Hossein Hospital, Ayatollah Towhidi Avenue
City
Shahroud
Postal code
3616911151
Phone
+98 23 3234 2001
Fax
Email
javadnourian@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)