Comparison of the effectiveness of low-dose Esmolol and Labetalol on changes in heart rate and blood pressure in patients treated with electroshock (ECT)
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Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Leyla Rafiei
Full name of responsible person - Persian: لیلا رفیعی
Position - English: Nurse Anesthesia
Position - Persian: پرستار بیهوشی
Latest degree: bachelor
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 223-9, unit.8, Aria bilding, West Kargar Alley, Farabi 3 Ave, Sepahan Shahr
Street address - Persian: سپاهان شهر خیابان فارابی3 کوچه کارگر غربی ساختمان آریا پلاک 9-223واحد 8
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8179965545
Phone: +98 31 3650 3146
Mobile: +98 913 109 4043
Fax:
Email: leylarafiei943@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Leyla Rafiei
Full name of responsible person - Persian: لیلا رفیعی
Position - English: Nurse Anesthesia
Position - Persian: پرستار بیهوشی
Latest degree: bachelor
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hezar Jarib
Street address - Persian: هزارجریب
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8146713543
Phone: +98 31 3620 2020
Mobile: +98 913 109 4043
Fax:
Email: leylarafiei943@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Leyla Rafiei Full name of responsible person - Persian: لیلا رفیعی Position - English: Nurse Anesthesia Position - Persian: پرستار بیهوشی Latest degree: bachelor Area of specialty/work: 24 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No. 223-9, unit.8, Aria bilding, West Kargar Alley, Farabi 3 Ave, Sepahan ShahrHezar Jarib Street address - Persian: سپاهان شهر خیابان فارابی3 کوچه کارگر غربی ساختمان آریا پلاک 9-223واحد 8هزارجریب City - English: Isfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81799655458146713543 Phone: +98 31 3650 31463620 2020 Mobile: +98 913 109 4043 Fax: Email: leylarafiei943@gmail.com Web page address:
Protocol summary
Study aim
Comparison of the effect of prophylactic injection of low doses of esmolol and labetalol on changes in heart rate and blood pressure in electroshock therapy (ECT)
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 90 patients. Random Allocation software is used for randomization
Settings and conduct
This is a double-blind clinical trial study in which the target population is ETC candidate patients at Al-Zahra Hospital in Isfahan. Patients are randomly assigned to three groups: C, B, and A, and each group is randomly injected into one of the three intervention groups. The patient's vital signs are checked and recorded before, during, and after ECT. The injector, the clinical caregiver and the patient are unaware of the injected intervention and are blind.
Participants/Inclusion and exclusion criteria
ECT candidate patients between the ages of 13 and 19 with class I and II ASA will be included in the study if they do not have a specific underlying problem.
Intervention groups
A group: 0.2 mg/kg Labetalol
B group: 0.5 mg/kg Esmolol
C group: Normal saline as pelacebo
Main outcome variables
Heart Rate; Blood Pressure
General information
Reason for update
Acronym
ECT
IRCT registration information
IRCT registration number:IRCT20160307026950N19
Registration date:2020-06-02, 1399/03/13
Registration timing:prospective
Last update:2022-07-12, 1401/04/21
Update count:1
Registration date
2020-06-02, 1399/03/13
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
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of low-dose Esmolol and Labetalol on changes in heart rate and blood pressure in patients treated with electroshock (ECT)
Public title
Esmolol and Labetalol in ECT
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for electroshock therapy
Range of 13 to 19 years
ASA class I and II
The patient's consent to participate in the study
Exclusion criteria:
Contraindications to the use of Esmolol and Labetalol
Previous consumption of beta-blockers
Sensitivity to Esmolal and labetalol
Asthma and drug allergies
History of severe cardiovascular disease, chronic respiratory disease, kidney disease, and liver disease
Age
From 13 years old to 19 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way and patients are distributed in intervention and control groups using Random Allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs and placebo are packaged in the same form with the same volume and coded and are randomly distributed among patients, so the participant and the clinical and evaluator are not aware of the type of drug.
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
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-05-01, 1399/02/12
Ethics committee reference number
IR.MUI.MED.REC.1399.105
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 prescribing Esmolal, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock.
Method of measurement
ECG monitoring and Pulse Oximeter
2
Description
Systolic Blood Pressure
Timepoint
Before prescribing Esmolol, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock.
Method of measurement
Non-invasive blood pressure measurement
3
Description
Diastolic Blood Pressure
Timepoint
Before prescribing Esmolol, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock.
Method of measurement
Non-invasive blood pressure measurement
4
Description
Mean Arterial Pressure
Timepoint
Before prescribing Esmolol, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock.
Method of measurement
Non-invasive blood pressure measurement
Secondary outcomes
1
Description
Oxygen saturation
Timepoint
Before prescribing Esmolol, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock.
Method of measurement
Pulse oximeter
2
Description
The duration of the seizure
Timepoint
Beginning to the end of the seizure
Method of measurement
Chronometer
3
Description
The duration of anesthesia
Timepoint
Beginning to the end of the anesthesia
Method of measurement
Chronometer
4
Description
Recovery time
Timepoint
From the end of anesthesia to full awakening
Method of measurement
Watch
5
Description
Nausea and Vomiting
Timepoint
During the stay in the recovery
Method of measurement
Ask the patient about this complication
6
Description
Headache
Timepoint
During the stay in the recovery
Method of measurement
Asking from the patient
7
Description
Larangospasm
Timepoint
During the stay in the recovery
Method of measurement
Monitoring
Intervention groups
1
Description
Intervention Group A; Labethalol is administered at a dose of 0.2 mg per kg body weight prior to anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group B; Esmolol is injected 0.5 mg per kilogram of body weight prior to anesthesia.
Category
Treatment - Drugs
3
Description
Control group C; Normal saline is injected into the patient as a placebo before injecting the anesthetic.
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
Zahra Mirelahi
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?
Yes
Title of funding source
Esfahan 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 Mirelahi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 2,Nabovvat Ave, Reza Abbasi Blvd, Ale Mohmmad St, Chamran High way
City
Isfahan
Province
Isfehan
Postal code
8193713448
Phone
+98 31 3568 5233
Email
zmirelahi1994@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemoroaya
Position
Professor assistant of Anesthesia and Intensive carentensive care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjarib Street
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
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