Protocol summary

Study aim
Determining the effect of propofol with or without ketamine on the result of the Montreal test in patients with mood disorders treated with electroshock in Imam Hossein (AS) hospital in 1402
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase one on 88 patients. In both groups, the day before the ECT treatment, one day after the end of the ECT treatment, and one month after the last ECT treatment session, the Montreal cognitive test will be performed, and the effect of ketamine will be compared on cognition
Settings and conduct
The study population is selected from the Imam Hossein Hospital, diagnosed with any type of mood disorders (unipolar, bipolar, with or without psychosis, and major depressive disorder) based on DSM-5 criteria and identified by a psychiatrist as requiring ECT treatment. After obtaining informed consent, the patients will undergo a comprehensive psychiatric evaluation and physical examination by a psychiatry resident. Patients meeting the inclusion and exclusion criteria will be enrolled in the study. Allocation concealment will be accomplished by placing cards inside opaque, sealed, and sequentially numbered envelopes (Sequence Numbered Sealed Opaque Envelopes - SNOSE)
Participants/Inclusion and exclusion criteria
Persian-speaking 18-70 year old patients diagnosed with mood disorders (bipolar I or II, with/without psychosis, major depression) requiring ECT treatment, with no neurological/cognitive diseases or alcohol use in the past 14 days or opioid/amphetamine use in the past month.
Intervention groups
the intervention group, induction of general anesthesia will be performed using Pofol injection and simultaneous injection of intravenous ketamine hydrochloride, and in the control group, induction of general anesthesia will be performed using only Pofol.
Main outcome variables
Pre and post(1 month after)ECT montreal test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231217060435N1
Registration date: 2024-03-31, 1403/01/12
Registration timing: prospective

Last update: 2024-03-31, 1403/01/12
Update count: 0
Registration date
2024-03-31, 1403/01/12
Registrant information
Name
Alireza Zaribaf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 210 0551
Email address
ar.zaribaf@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"The Effects of Propofol With and Without Ketamine on Montreal Cognitive Assessment Test Results in Patients With Mood Disorders Undergoing Electroconvulsive Therapy"
Public title
"The Effects of Propofol With and Without Ketamine on Montreal Cognitive Assessment Test Results in Patients With Mood Disorders Undergoing Electroconvulsive Therapy"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients With Mood Disorders Undergoing Electroconvulsive Therapy" People with an age range of 18 to 70 years who have a primary education level and above Proficiency in Persian language
Exclusion criteria:
Previous treatment with electroshock in the last six months Neurocognitive diseases such as Alzheimer's, Parkinson's, etc History of neurological disorders such as stroke, tumor or any brain injury
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Random distribution of high people after matching with age and education by observing the principle of ignorance by creating a random sequence Random Sequence Generation will be done in the form of simple randomization and through cards shuffling. So that a number of cards will be prepared as the first group and the same number of cards will be prepared for the next group. is taken out and its allocation is recorded and that card is returned to the sum of other cards. Then the cards are dealt again and another card is taken out. This process will continue until reaching a random sequence according to the sample size. Found.
Blinding (investigator's opinion)
Double blinded
Blinding description
Allocation concealment will be achieved by placing cards containing information about patient assignment to different treatment groups (propofol with ketamine or propofol alone) in sequentially numbered, opaque, sealed envelopes (Sequence Numbered Sealed Opaque Envelopes - SNOSE). For further explanation: The envelopes containing the group assignment cards will be prepared and sequentially numbered by an independent individual not involved in the study conduct or patient evaluation. The envelopes will be opened in the order of patient enrollment, and patients will be assigned to one of the treatment groups based on the contents of the envelope. The physicians and MoCA evaluators will be blinded to the treatment received by the patients. Data analysis will also be performed by a statistician who is unaware of the patient grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
Street address
Valenjak Street, daneshjo Blvd., Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-12-03, 1402/09/12
Ethics committee reference number
IR.SBMU.MSP.REC.1402.481

Health conditions studied

1

Description of health condition studied
Major depressive disorder
ICD-10 code
F33
ICD-10 code description
Major depressive disorder, recurrent

2

Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder

Primary outcomes

1

Description
The result of the Montreal test
Timepoint
In both groups, before the first session and before anesthesia, after the final and sixth session of ECT and one month after the end of the treatment, the Montreal cognitive test will be repeated.
Method of measurement
Montreal Cognitive Assessment Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group 1: After intravenous line insertion, general anesthesia is induced using intravenous propofol 1 mg/kg along with intravenous succinylcholine 20 mg and intravenous atropine 0.25 mg. Simultaneously, intravenous ketamine hydrochloride 0.8 mg/kg from Rotexmedica ketamine vial (50 mg/10 ml) is administered as a bolus.
Category
Treatment - Drugs

2

Description
Control group:After intravenous line insertion, general anesthesia is induced using intravenous propofol 1 mg/kg along with intravenous succinylcholine 20 mg and intravenous atropine 0.25 mg. However, they do not receive ketamine
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Alireza Zaribaf
Street address
Madani Street, Imam Hossein Hospital, Psychiatry Building, Department Head's Office
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 913 210 0551
Email
ar.zaribaf@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Seyed Ali ziayi
Street address
Daneshjo Blvd Shahid Beheshti University Of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1984845497
Phone
+98 913 210 0551
Email
ar.zaribaf@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Zaribaf
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Daneshjo Blv Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 913 210 0551
Email
ar.zaribaf@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Zaribaf
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 913 210 0551
Email
ar.zaribaf@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Zaribaf
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 913 210 0551
Email
ar.zaribaf@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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