Comparison of cardiovascular changes and serum potassium levels in the use of succinylcholine and cisatracurium drugs in electroshock therapy.
Design
This study was a cross-over, double-blind, randomized,45 patients who were in the Phase 3 trial were designed.
Settings and conduct
This is a double-blind clinical trial that was performed on 45 patients with electroshock candidate who were referred to Al-Zahra Hospital. patients were randomly assigned to two groups and Then they were placed in two Sequence and two Period with packages (a) and (b) under the electroshock. The person who prescribes the drug and the person who registers the vital signs are different and are unaware of the contents of the packages.. Cardiac monitoring includes electrocardiogram, heart rate, pulse oximetry and noninvasive blood pressure for all patients is done. Heart rate Median arterial blood pressure Diastolic and systolic blood pressure Hemoglobin saturation of oxygen is measured in 4 times.
Participants/Inclusion and exclusion criteria
The criteria for entering this study include those under the age of 18 years and the physical status of Classes one and two. Also, non-compliance criteria include high obesity , history of asthma, allergies, heart attacks , stroke , fibrillation and flutter.
Intervention groups
The method was done so that patients were randomly assigned to two groups and Then they were placed in two Sequence and two Period with packages (a) and (b) under the electroshock.The package (a) contains 1.5 mg of ketamine per kg of body weight and 0.5 mg of succinylcholine per kg of body weight
Package (b) contains 1.5 mg of ketamine per kg of body weight and 50 µg of cisatracurium per kg of body weight
Main outcome variables
Serum potassium level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N14
Registration date:2019-07-18, 1398/04/27
Registration timing:retrospective
Last update:2019-07-18, 1398/04/27
Update count:0
Registration date
2019-07-18, 1398/04/27
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
2018-12-06, 1397/09/15
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
2019-03-06, 1397/12/15
Actual recruitment end date
2019-04-14, 1398/01/25
Trial completion date
2019-05-05, 1398/02/15
Scientific title
Comparison of cardiovascular changes and serum potassium levels in the use of succinylcholine and cisatracurium drugs in electroshock therapy
Public title
The effect of two drugs succinylcholine and cisatracurium in electroshock therapy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People under the age of 18
American Society of Anesthesiology physical status class 1,2
Exclusion criteria:
Obesity (index is equal to or greater than 30
History of asthma
Allergy
Myocardial infarction in the last 6 months
Stroke in the last 6 weeks
Fibrillation and cardiac flutter
Repeated ectopic treatment at the same session
Having diseases like high blood pressure and hyperactivity
Age
From 11 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
.Patients were randomly assigned to two groups A and B, using Random Allocation software, and compared in two Sequence and two Period (AB, BA)
Blinding (investigator's opinion)
Double blinded
Blinding description
Both drugs are prepared by the researcher using syringes of the same form and size, and the person who prescribes the drug and the person who registers the vital signs are different and are unaware of the contents of the packages.
Placebo
Not used
Assignment
Crossover
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
81746-73461
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.MUI.MED.REC.1397.279
Health conditions studied
1
Description of health condition studied
Succinylcholine Chloride
ICD-10 code
T48.1X3
ICD-10 code description
Poisoning by skeletal muscle relaxants [neuromuscular blocking agents], assault
2
Description of health condition studied
cisatracurium
ICD-10 code
T48.1X3
ICD-10 code description
Poisoning by skeletal muscle relaxants [neuromuscular blocking agents], assault
Primary outcomes
1
Description
serum potassium levels
Timepoint
Before the administration of the anesthetic (baseline), before induction of the Electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia
Method of measurement
potassium test
Secondary outcomes
1
Description
Heart rate changes
Timepoint
Before the administration of the anesthetic (baseline), before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia
Method of measurement
Heart monitoring
2
Description
Systolic blood pressure
Timepoint
Before the administration of the anesthetic (baseline), before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia
Method of measurement
Non invasive blood pressure monitor
3
Description
Diastolic blood pressure
Timepoint
Before the administration of the anesthetic (baseline), before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia
Method of measurement
Non invasive blood pressure monitor
4
Description
Mean arterial pressure
Timepoint
Before the administration of the anesthetic (baseline), before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia
Method of measurement
Non invasive blood pressure monitor
5
Description
Oxygen saturation
Timepoint
Before the administration of the anesthetic (baseline), before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia
Method of measurement
Percent with pulse oximeter
6
Description
Recovery time
Timepoint
From the end of seizure to full consciousness
Method of measurement
In minutes using a stopwatch
Intervention groups
1
Description
Intervention group: After obtaining a license from the Medical Ethics Committee of Isfahan University of Medical Sciences, patients who are willing to participate in the study. In the first period with the package (b) containing 1.5 mg / kg of ketamine and 50 μg / kg of cis-atracurium and in the second period with the package (a) containing 1.5 mg / kg of ketamine and mg/kg 0.5 of succinylcholine taken under electroshock therapy. And from the right hand, blood samples are taken at the time before administration of the anesthetic drug (baseline) before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia. before induction Anesthesia is provided for patients with a simple oxygen mask and given 4 to 6 liters of oxygen for a period of three minutes. Heart monitoring includes electro-cardiogram and heart rate, pulse oximetry and non-invasive blood pressure for all patients. Heart rate, mean arterial blood pressure, diastolic blood pressure and systolic blood pressure and hemoglobin saturation from oxygen are measured at these times.
Category
Treatment - Drugs
2
Description
Control group: After obtaining a license from the Medical Ethics Committee of Isfahan University of Medical Sciences, patients who are willing to participate in the study. In the first period with the package (a) containing 1.5 mg / kg of ketamine and mg/kg 0.5 of succinylcholine and in the second period with the package (b) containing 1.5 mg / kg of ketamine and 50 μg / kg of cis-atracurium taken under electroshock therapy. And from the right hand, blood samples are taken at the time before administration of the anesthetic drug (baseline) before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia. before induction Anesthesia is provided for patients with a simple oxygen mask and given 4 to 6 liters of oxygen for a period of three minutes. Heart monitoring includes electro-cardiogram and heart rate, pulse oximetry and non-invasive blood pressure for all patients. Heart rate, mean arterial blood pressure, diastolic blood pressure and systolic blood pressure and hemoglobin saturation from oxygen are measured at these times.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Behzad Nazemalroaya
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
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
Atefeh Ghosouri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
dehkhoda street
City
shahinshahr
Province
Isfehan
Postal code
8316673200
Phone
+98 31 4536 2385
Email
ghosouriatefeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemalroaya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Soffeh boulevard, Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 36202020
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
Atefeh Ghosouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Dehkhoda
City
shahinshahr
Province
Isfehan
Postal code
8316673200
Phone
+98 45362385
Email
ghosouriatefeh@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