A comparative study of heart rate and blood pressure changes during and after electroconvulsive therapy followed by two different doses of labetalol in two groups of patients
A comparative study of heart rate and bloodpressure changes during and after elecrtoconvulsive therapy followed by two different doses of labetalol in two groups of patients
Design
This study will be conducted in parallel, double-blind, randomized, 40 people who are in the Phase 3 trial.
Settings and conduct
Patients are referred to pediatric psychology ward of al-Zahra hospital. The patients are randomly divided into two groups.For all intervention groups, informed consent is obtained from the parents of patients. Then an appropriate peripheral vein is taken from the patients and the blood pressure and electrocardiography and pulse oximetry devices are connected to the patients.group A recieve 0.2 mg/kg labetalol and group B recieve 0.4 mg/kg labetalol.the haert rate and blood pressure of each patient is detected.
The Participants, Care provider, Outcome assessor, and Data analyser are not aware of the drug type and the investigator deciphers the codes after data analysis.
Participants/Inclusion and exclusion criteria
inclusion criteria :
patients candidates receiving electroconvulsive therapy
Subjects older than 6 years old and younger than 25 years old
American Society of Anesthesiology physical status class 1,2 (ASAI, II)
Exclusion criteria:
subjects with severe cardiovascular disease, kidney disease, Liver disease, respiratory disease, drugs Allergy
Intervention groups
All patients recieve 0.5 mg/kg succinylcholine and 2mg/kg thiopental sodium. Intervention group A recieves 0.2 mg/kg labetalol and Intervention group B recieves 0.4mg/kg labetalol.
Main outcome variables
blood pressure and heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N11
Registration date:2019-05-27, 1398/03/06
Registration timing:retrospective
Last update:2019-05-27, 1398/03/06
Update count:0
Registration date
2019-05-27, 1398/03/06
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
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of heart rate and blood pressure changes during and after electroconvulsive therapy followed by two different doses of labetalol in two groups of patients
Public title
Effects of two different doses of labetalol on electroconvulsive therapy in two groups of patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients candidates receiving electroconvulsive therapy
Subjects older than 6 yeras old and younger than 25 years old
American society of anesthesiology physical status class 1,2 (ASAI,II)
Exclusion criteria:
Severe cardiovascular disease
Severe respiratory disease
Severe kidney disease
Severe Liver disease
Drugs Allergy
Age
From 6 years old to 25 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to two groups A, B using the Random Allocation computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
All drugs are in one form and in the form of a volume in the syringe by the researcher, and the hemodynamic changes are monitored and recorded, so the attending and the clinical caregiver and the evaluator do not understand the type of medication.
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
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-27, 1396/03/06
Ethics committee reference number
IR.MUI.REC.1396.3.677
Health conditions studied
1
Description of health condition studied
Heart rate and blood pressure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Heart rate changes
Timepoint
Before the intervention, 1 , 5, 10 minutes after intervention and then After The discharge time of recovery
Method of measurement
Pulse oximetry device
2
Description
Mean arterial blood pressure
Timepoint
Before the intervention,1 , 5, 10 minutes after intervention and then After The discharge time of recovery
Method of measurement
Non invasive blood pressure
3
Description
Oxygen saturation
Timepoint
Before the intervention, 1 , 5, 10 minutes after intervention and then After The discharge time of recovery
Method of measurement
Pulse oximetry device
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
After end of the siezure
Method of measurement
Questionnaire
2
Description
laryngospasm
Timepoint
After end of the siezure
Method of measurement
Questionnaire
3
Description
Duration of seizure
Timepoint
After intervention
Method of measurement
In seconds using a chornometer
4
Description
Recovery duration
Timepoint
From the end of seizure to full consciousness
Method of measurement
Minute with using a chornometer
Intervention groups
1
Description
Intervention group A: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached.all patients recieve 0.5 mg/kg succinylcholine and 2mg/kg thiopental sodium. In this group 0.2 mg/kg labetalol is injected.
Category
Treatment - Drugs
2
Description
Intervention group B: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached.all patients recieve 0.5 mg/kg succinylcholine and 2mg/kg thiopental sodium. In this group 0.4 mg/kg labetalol is injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Soffeh boulevard, Shahid Kesari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
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
Shaghyegh Haghjoo
Street address
HezarJarib Street
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
Negar Rezaei
Position
Medical student/ Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shikh Sadogh Ave.,Shahid Noorolahi Alley.
City
Isfahan
Province
Isfehan
Postal code
8163863697
Phone
+98 31 3666 0225
Email
negarrezaei968@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
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar jarib 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
Negar rezaie joochi
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sheykh saddough street
City
Isfahan
Province
Isfehan
Postal code
8163863697
Phone
+98 31 3666 0225
Email
negarrezaei968@gmail.com
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