Protocol summary
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Study aim
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Comparison of atracurium and succinylcholine in anesthesia for patients receiving electroshock therapy
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Design
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A double-blinded and randomized clinical trial with parallel groups design of 64 patients
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Heart rate,blood pressure,recovery time, side effects
General information
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Reason for update
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َAt first the appropriate sample size for each group was considered 15, which due to the circumstances indicating a deficiency of the drug saxinylcholine, the researchers of this project needed to use atracurium as an alternative drug in more cases.As a result, this number increased to 32 people per group.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170314033069N2
Registration date:
2020-11-01, 1399/08/11
Registration timing:
registered_while_recruiting
Last update:
2021-11-01, 1400/08/10
Update count:
1
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Registration date
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2020-11-01, 1399/08/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-10-22, 1399/08/01
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Expected recruitment end date
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2021-04-21, 1400/02/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of atracurium and succinylcholine in anesthesia outcomes among patients receiving Electroconvulsive therapy (ECT) , a parallel and double blind clinical trial
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Public title
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Comparison of atracurium and succinylcholine in patients undergoing ECT
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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).
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-10-07, 1399/07/16
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Ethics committee reference number
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IR.GUMS.REC.1399.323
Health conditions studied
1
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Description of health condition studied
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Investigation of using atracurium instead of succinylcholine for anesthesia in electroshock therapy in cases that there is a contraindication for succinylcholine
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ICD-10 code
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T88.5
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ICD-10 code description
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Other complications of anesthesia
Primary outcomes
1
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Description
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Systolic and diastolic blood pressure ( millimeters Hg)
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Timepoint
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Base time and 15 minutes after Electroshock
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Method of measurement
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Blood pressure measurement
2
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Description
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Heart rate (pulse/ minute)
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Timepoint
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Base time and 15 minutes after Electroshock
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Method of measurement
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Heart rate monitor
Secondary outcomes
1
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Description
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Recovery time
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Timepoint
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The time that patients stay in recovery room due to awareness and returning of spontaneous breathing, that is about 15 to 20 minutes
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Method of measurement
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Aldret score
2
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Description
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Complications
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Timepoint
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recovery time and in ward
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Method of measurement
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headache, myalgia, bradycardia, master spasm, dysrhythmia
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice President of Research Guilan university of medical sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available