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The investigation of the effect of adding Dexmedetomidine to Propofol on changes in heart rate and blood pressure in pediatric Electroconvulsive therapy

Protocol summary

Study aim
Evaluation of the effect of adding Dexmedetomidine to Propofol in pediatric Electroconvulsive therapy
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients. Lottery was used for randomization.
Settings and conduct
This study is a randomized, double-blind clinical trial that will be performed on children who are candidates for electroconvulsive therapy at Al-Zahra Hospital in Isfahan. Before the arrival of patients, their parents will be informed about the study and if they are satisfied, they will be prepared and monitored for the intervention. Patients are randomly distributed in two groups and each group receives the relevant intervention after propofol injection. The clinical caregiver is different from the person injecting the drug and is unaware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 4 to 16 years old, ECT candidate, ASA class I and II anesthesia Exclusion criteria: History of seizures, Heart failure, Kidney failure, Liver failure, Respiratory failure, History of allergy to the studied drugs, Addiction to psychotropic substances, History of egg allergy
Intervention groups
Intervention group A: In this group, after injecting propofol, patients are injected with 0.5 mg of dexmedetomidine per kg of body weight. Intervention group B: In this group, after injection of propofol, patients are injected with 0.5 ml of normal saline.
Main outcome variables
Heart rate changes; Changes in blood pressure

General information

Reason for update
Acronym
ETC نام اختصاری Electro Convulsive Therapy میباشد.
IRCT registration information
IRCT registration number: IRCT20160307026950N29
Registration date: 2020-12-21, 1399/10/01
Registration timing: prospective

Last update: 2020-12-21, 1399/10/01
Update count: 0
Registration date
2020-12-21, 1399/10/01
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
2020-12-30, 1399/10/10
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of the effect of adding Dexmedetomidine to Propofol on changes in heart rate and blood pressure in pediatric Electroconvulsive therapy
Public title
The effect of Dexmedetomidine in pediatric Electroconvulsive therapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children 4 to 16 years Candidate for ETC ASA Class I & II
Exclusion criteria:
Patients with a history of seizures, Heart failure, Kidney failure, Liver failure, Respiratory failure History of allergy to the studied drugs Addiction to psychotropic substances History of egg allergy
Age
From 4 years old to 16 years old
Gender
Both
Phase
3
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 done by block method; In this way, the first patient enters one of the groups by drawing lots, then from the second patient, the patients enter the two groups one by one, so that their number in each group reaches 35 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study; As the clinical caregiver is different from the person injecting the drug and is unaware of the type of intervention, patients are also unaware of the type of intervention applied and are therefore blind.
Placebo
Used
Assignment
Parallel
Other design features
In this study, awareness and consent of patients' parents is obtained.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences Committe for Ethics in Biomedical Research
Street address
Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-03-01, 1398/12/11
Ethics committee reference number
IR.MUI.MED.REC.1398.638

Health conditions studied

1

Description of health condition studied
Blood Pressure
ICD-10 code
R03.0
ICD-10 code description
Elevated blood-pressure reading, without diagnosis of hypertension

2

Description of health condition studied
Heart Rate
ICD-10 code
R00.0
ICD-10 code description
Tachycardia, unspecified

Primary outcomes

1

Description
Heart Rate
Timepoint
Before drug injection and 1, 2, 3, 5 and 10 minutes after anesthesia
Method of measurement
ECG

2

Description
Blood Pressure
Timepoint
Before drug injection and 1, 2, 3, 5 and 10 minutes after anesthesia
Method of measurement
Manometer

Secondary outcomes

1

Description
Duration of anesthesia
Timepoint
From the beginning of anesthesia to the end of recovery
Method of measurement
Timer

2

Description
Duration of seizures
Timepoint
From the moment of the beginning of contractions until the time of relaxation
Method of measurement
Timer

Intervention groups

1

Description
Intervention group A: Patients in this group after lying on the bed and monitoring connection with 0.5 mg per kg body weight SuccinylCholine, 2 mg per kg body weight Thiopental and 1 mg Propofol per kg body weight and then 0.5 mg / kg Dexmedetomidine is anesthetized and Electroconvulsive therapy is initiated. Patients are recorded during ECT until the end of monitor recovery and changes in vital signs.
Category
Prevention

2

Description
Control group B: Patients in this group after lying on the bed and monitoring connection with 0.5 mg per kg body weight Succinylcholine, 2 mg per kg body weight Thiopental and 1 mg Propofol per kg body weight and then 0.5 ml of normal saline is anesthetized and Electroconvulsive therapy is initiated. Patients are recorded during ECT until the end of monitor recovery and changes in vital signs.
Category
Placebo

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
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
Dorna Masaely
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
m_dorna@yahoo

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Esfahan University of Medical Sciences
Position
Professor assistant of Anesthesia and Intensive carentensive care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib
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
Leyle Rafiei
Position
Nurse Anesthesia
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib
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
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