Comparison of the effect of low dose Ketamine and Midazolam injection with low dose Ketamine and Dexmedetomidine on changes in heart rate and blood pressure in Electroconvulsive therapy
Introducing an ideal method for controlling blood pressure, heart rate and respiratory parameters during various surgeries, especially electroconvulsive therapy
Design
Clinical trial with parallel, double-blind, randomized, phase 2 groups on 70 patients. Randomization is simple and patients are admitted to one of the two groups according to the time of admission.
Settings and conduct
This trial will be performed in the ECT ward of Al-Zahra Hospital in Isfahan; In this way, after obtaining permission from the University Medical Ethics Committee and obtaining patient satisfaction, 70 patients are selected as candidates for electroconvulsive therapy and randomly distributed in two groups of 35 people and each group will be injected with one of the therapeutic interventions. The patient's vital signs will be recorded. Patients and clinical caregivers are unaware of the injected drug and are blind.
Participants/Inclusion and exclusion criteria
All patients 18 to 65 years old who are candidates for electroconvulsive therapy who do not have a history of a specific disease can be included in the study if they agree.
Intervention groups
Intervention group A; 0.1 mg / kg ketamine with 0.04 mg / kg midazolam and intervention group B; They receive 0.1 mg / kg ketamine at a dose of 0.5 μg / kg dexmedetomidine before induction of anesthesia.
Main outcome variables
Heart Rate; Blood Pressure, Oxygen Saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N23
Registration date:2020-09-14, 1399/06/24
Registration timing:prospective
Last update:2020-09-14, 1399/06/24
Update count:0
Registration date
2020-09-14, 1399/06/24
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
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of low dose Ketamine and Midazolam injection with low dose Ketamine and Dexmedetomidine on changes in heart rate and blood pressure in Electroconvulsive therapy
Public title
The effect of the combination of Ketamine and Midazolam as well as a combination of ketamine and dexmedetomidine in Electroshock therapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for Electroconvulsive Therapy
Age 18 to 65
Patient consent to study
Exclusion criteria:
History of drug allergy
History of cardiovascular disease
Age
From 18 years old to 65 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
Randomization is a simple method; In this way, the first patient is assigned to one of the groups by lottery and the next patients are distributed consecutively and one in between in two groups so that the sample size reaches the required number in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blinding is that patients are unaware of the type of drug received and also the executor of the project will be unaware of the type of injectable drug to patients. In this way, the drugs are prepared and coded in similar syringes by one of the operating room personnel who is not in the process of study, and are given to the executor for injection.
Placebo
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
Hezar jarib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-05-27, 1399/03/07
Ethics committee reference number
IR.MUI.MED.REC.1399.377
Health conditions studied
1
Description of health condition studied
ElectroConvulsive Therapy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Heart Rate
Timepoint
Before drug injection, after drug injection, after shock termination, 5 and 10 minutes after end of seizure
Method of measurement
ECG monitoring
2
Description
Blood Pressure
Timepoint
Before drug injection, after drug injection, after shock termination, 5 and 10 minutes after end of seizure
Method of measurement
Non-invasive blood pressure measurement
3
Description
Oxygen Saturation
Timepoint
Before drug injection, after drug injection, after shock termination, 5 and 10 minutes after end of seizure
Method of measurement
Pulse Oxymeter
Secondary outcomes
1
Description
Duration of seizures
Timepoint
From the beginning to the end of the seizure
Method of measurement
Chronometer
2
Description
Complications after anesthesia
Timepoint
From the time of drug discontinuation to the end of recovery
Method of measurement
View patient status
3
Description
Recovery time
Timepoint
From stopping the drug to full consciousness
Method of measurement
Chronometer
Intervention groups
1
Description
Intervention group A: The patient will receive 0.1 mg / kg of Ketamine and 0.04 mg / kg of Midazolam.
Category
Treatment - Drugs
2
Description
Intervention group B: The patient will receive 0.1 mg per kg bodyweight of Ketamine and 0.5 micrograms per kg body weight of Dexmedetomidine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Behzad Nazemoroaya
Street address
Soffeh boulevard, Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
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
Shaghayegh Haghjoo
Street address
Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, 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
Zahra Manian
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
Zahra.maniann@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazem roaya
Position
Professor assistant of Anesthesia and Intensive carentensive care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leyla Rafiei
Position
Nurse Anesthesia
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
leylarafiei943@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