Comparison of atracurium and succinylcholine in anesthesia outcomes among patients receiving Electroconvulsive therapy (ECT) , a parallel and double blind clinical trial
Comparison of atracurium and succinylcholine in anesthesia for patients receiving electroshock therapy
Design
A double-blinded and randomized clinical trial with parallel groups design of 30 patients
Settings and conduct
This study will be done as a clinical trial at shafa Hospital in Rasht. Informed consent will be taken from patients and if not possible to communicate,it will be obtained from the patient's legal companion.procedure is the same for both groups.Standard monitoring is performed first, then atropine 0.5 milligrams will be prescribed.Blood pressure and heart rate will be recorded at baseline and 15 minutes after electroshock.All the necessary arrangements for emergency airway management will be available.After induction of anesthesia and administration of relaxant,patients will be electroshocked.Their spontaneous breathing and level of consciousness will be monitored for 15 to 20 minutes in recovery ward.By gaining 9 to 10 points based on the aldret scale discharge will be announced.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18 years and older, ASA I, II,normal body mass index,no criteria for difficult mask ventilation,no contraindications for succinylcholine and atracurium
Exclusion criteria:Endotracheal intubation or cardiac arrest during study
Intervention groups
succinylcholine group:Induction of anesthesia with 1.5 milligrams per kilogram propofol and 0.5 milligrams per kilogram succinylcholine
Atracurium group: Induction of anesthesia with 1.5 milligrams per kilogram propofol and 0.2 milligrams per kilogram atracurium.0.04 milligrams per kilogram neostigmine and 0.02 milligrams per kilogram atropine will be prescribed as a reversal for muscle relaxant effect.
Main outcome variables
Heart rate,blood pressure,recovery time, side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170314033069N2
Registration date:2020-11-01, 1399/08/11
Registration timing:registered_while_recruiting
Last update:2020-11-01, 1399/08/11
Update count:1
Registration date
2020-11-01, 1399/08/11
Registrant information
Name
Gelare Biazar Biazar
Name of organization / entity
Guilan University of Medical Sciences,Alzahra Hospital
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9024
Email address
biazar@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of atracurium and succinylcholine in anesthesia outcomes among patients receiving Electroconvulsive therapy (ECT) , a parallel and double blind clinical trial
Public title
Comparison of atracurium and succinylcholine in patients undergoing ECT
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 years and older
ASA class I,II
Normal body mass index
No criteria for difficult mask ventilation
No contraindication for atracurium and succinylcholine
Exclusion criteria:
Endotracheal intubation during study
Cardiac arrest during study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided in two groups by an anesthesia technician who does not participate in the project, using four random blocks created by the computer (https://www.sealedenvelope.com/).
This is done through a list of eligible patients who have given informed consent.They will be assigned to one of the two groups receiving saxinylcholine or atracurium by a sequence of randomization blocks in a 1: 1 ratio.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study in which patients and the two trained technicians who evaluate and record the information, are unaware of the treatment groups. The anesthesiologist who is in charge is aware of the groups to take the necessary interventions in case of complications (headache, myalgia, bradycardia,masseter spasm, dysrhythmia).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti Freeway
City
Rasht
Province
Guilan
Postal code
4144654839
Approval date
2020-10-07, 1399/07/16
Ethics committee reference number
IR.GUMS.REC.1399.323
Health conditions studied
1
Description of health condition studied
Investigation of using atracurium instead of succinylcholine for anesthesia in electroshock therapy in cases that there is a contraindication for succinylcholine
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Systolic and diastolic blood pressure ( millimeters Hg)
Timepoint
Base time and 15 minutes after Electroshock
Method of measurement
Blood pressure measurement
2
Description
Heart rate (pulse/ minute)
Timepoint
Base time and 15 minutes after Electroshock
Method of measurement
Heart rate monitor
Secondary outcomes
1
Description
Recovery time
Timepoint
The time that patients stay in recovery room due to awareness and returning of spontaneous breathing, that is about 15 to 20 minutes
Atracurium intervention group: Before receiving anesthesia and electroshock therapy, standard monitoring of non-invasive blood pressure, pulse oximetry, electrocardiogram, and end-tidal carbon dioxide will be established and atropine 0.5 milligrams will be prescribed. After establishing a proper intravenous cateter size 20-18, induction of anesthesia with propofol 1.5 miligrams/kilograms and atracurium 0.2 miligrams/kilograms will be prescribed.
Category
Treatment - Drugs
2
Description
Succinylcholine control group: After establishing a proper venous catheter, induction of anesthesia with propel 1.5 milligrams/kilograms and succinylcholine 0.5 milligrams/kilograms will be prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Dr Gelareh Biazar
Street address
15 Khordad avenue
City
Rasht
Province
Guilan
Postal code
5559941939
Phone
+98 13 3366 2360
Email
hospital_shafa_rasht@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research Guilan university of medical sciences
Full name of responsible person
Dr Mohammadreza Naghipoor
Street address
Shahid Beheshti Freeway
City
Rasht
Province
Guilan
Postal code
6694941446
Phone
+98 13 3333 5821
Email
naghi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research Guilan 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
Anesthesiology Research Center
Full name of responsible person
Dr Gelareh Biazar
Position
associate professor, Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3332 9524
Fax
+98 13 3336 9024
Email
gelarehbiazar1386@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Research Center
Full name of responsible person
Dr Gelareh Biazar
Position
associate professor, Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3332 9524
Fax
+98 13 3336 9024
Email
gelarehbiazar1386@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohadese Ahmadi
Position
Research Expert/(MSc) English
Latest degree
Master
Other areas of specialty/work
Research Expert
Street address
Anestesiology Reseaech Center, Alzahra Hospital, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9328
Email
p.ahmadi2311@gmail.com
Web page address
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