Comparative study of the effect of thiopental sodium and propofol in electroconvulsive therapy on seizure duration and threshold changes based on electroencephalogram
Determination and comparison of the effects of thiopental sodium and propofol in electroconvulsive therapy on seizure duration and threshold changes
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 2 on 70 patients
Settings and conduct
In this randomized, double-blind clinical trial study, 70 eligible patients referred to Modares Hospital in Isfahan will be enrolled and randomly divided into two groups. Patients in the two groups will be prescribed succinylcholine with thiopental sodium or succinylcholine with propofol, respectively, before electroconvulsive therapy. In this study, the patient, data collector, and statistical analyst will be unaware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: candidates for ECT; over 18 years of age; not respond adequately to drug therapy; being at serious risk of suicide or harm to others if ECT was not administered; consent to participate in the study. Exclusion criteria: having a recent history of cardiovascular disease such as heart attack or congestive heart failure; having a brain tumor, cerebral aneurysm, or any increase in intracranial pressure; patients with uncontrolled heart failure; patients at risk of anesthesia (ASA level 4-5).
Intervention groups
First intervention group: In this group, patients receive 0.5 mg/kg of succinylcholine and 2 mg/kg of sodium thiopental before electroconvulsive therapy. Second intervention group: In this group, patients receive 0.5 mg/kg of succinylcholine and 1 mg/kg of propofol before electroconvulsive therapy.
Main outcome variables
Seizure time, Seizure threshold
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N71
Registration date:2025-09-06, 1404/06/15
Registration timing:prospective
Last update:2025-09-06, 1404/06/15
Update count:0
Registration date
2025-09-06, 1404/06/15
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
Expected recruitment start date
2025-09-22, 1404/06/31
Expected recruitment end date
2026-03-21, 1405/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of thiopental sodium and propofol in electroconvulsive therapy on seizure duration and threshold changes based on electroencephalogram
Public title
The effect of thiopental sodium and propofol in electroconvulsive therapy on seizure duration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for electroconvulsive therapy (such as patients with schizophrenia, major depression, bipolar disorder in the manic phase)
Over the age of 18
Patients who have not responded adequately to medication or the individual/guardian is willing to undergo electroconvulsive therapy
Patients who are at serious risk of suicide or harm to others if they do not receive electroconvulsive therapy
Consent to participate in the study
Exclusion criteria:
Having a recent history of cardiovascular diseases such as myocardial infarction or congestive heart failure
Having brain tumors, cerebral aneurysms or any increased intracranial pressure
Patients with uncontrolled heart failure
Patients at risk of anesthesia (ASA level 4-5)
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 70 eligible patients are randomly selected. For this, the letter A is written on 35 sheets, the letter B is written on 35 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to comply with the blinding conditions before electroconvulsive therapy, two drugs, thiopental sodium 2 mg/kg and propofol 1 mg/kg, are included in packages labeled A and B. Also, 0.5 mg/kg of succinylcholine is included in both packages. Thus, package A will contain succinylcholine and thiopental, and package B will contain succinylcholine and propofol. The interventionist will inject the drug without knowing the type of drug. Also, the patient will not be aware of the type of intervention. The data collector and statistician will not be aware of the type of therapeutic intervention in either group until after the data analysis is completed.
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, Building No 4, Isfahan University Of Medical Sciences, Hezarjirib Street
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2025-02-12, 1403/11/24
Ethics committee reference number
IR.MUI.MED.REC.1403.461
Health conditions studied
1
Description of health condition studied
Candidate for electroconvulsive therapy
ICD-10 code
Y84.9
ICD-10 code description
Medical procedure, unspecified as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Seizure time
Timepoint
During the electroconvulsive therapy process
Method of measurement
Time in minutes
2
Description
Seizure threshold
Timepoint
During the electroconvulsive therapy process
Method of measurement
Based on electrocardiogram (ECG)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: In this group, patients receive 0.5 mg/kg of succinylcholine and 2 mg/kg of sodium thiopental before electroconvulsive therapy.
Category
Treatment - Drugs
2
Description
Second intervention group: In this group, patients receive 0.5 mg/kg of succinylcholine and 1 mg/kg of propofol before electroconvulsive therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres hospital
Full name of responsible person
Behzad Nazemoroaya
Street address
Najafabad
City
Isfahan
Province
Isfehan
Postal code
8583151351
Phone
+98 31 4223 2085
Email
behzad_nazem@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Behzad Nazemroaya
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Al-Zahra Hospital, Safa Boulevard, Shahid Keshvari Highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
behzad_nazem@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Behzad Nazemroaya
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Al-Zahra Hospital, Safa Boulevard, Shahid Keshvari Highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Khatibi
Position
Non-academic specialist physician
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
Email
behzad_nazem@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD