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IRCT20170314033069N2 IRCT 2020-11-01 Vice President of Research Guilan university of medical sciences Comparison of atracurium and succinylcholine in patients undergoing ECT Comparison of atracurium and succinylcholine in anesthesia outcomes among patients receiving Electroconvulsive therapy (ECT) , a parallel and double blind clinical trial 2020-10-22 anticipated 64 Complete https://irct.ir/trial/51534 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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). 3 Investigation of using atracurium instead of succinylcholine for anesthesia in electroshock therapy in cases that there is a contraindication for succinylcholine. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is not decided yet
public Dr Gelareh Biazar
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 gelarehbiazar1386@gmail.com Anesthesiology Research Center scientific Dr Gelareh Biazar
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 gelarehbiazar1386@gmail.com Anesthesiology Research Center Iran (Islamic Republic of) 18 years and older ASA class I,II Normal body mass index No criteria for difficult mask ventilation No contraindication for atracurium and succinylcholine 18 years no limit Both Endotracheal intubation during study Cardiac arrest during study T88.5 Other complications of anesthesia Treatment - Drugs Treatment - Drugs 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. 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. Systolic and diastolic blood pressure ( millimeters Hg). Timepoint: Base time and 15 minutes after Electroshock. Method of measurement: Blood pressure measurement. Heart rate (pulse/ minute). Timepoint: Base time and 15 minutes after Electroshock. Method of measurement: Heart rate monitor. 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. Method of measurement: Aldret score. Complications. Timepoint: recovery time and in ward. Method of measurement: headache, myalgia, bradycardia, master spasm, dysrhythmia. Vice President of Research Guilan university of medical sciences Approved 2020-10-07 Ethics committee of Guilan University of Medical Sciences Shahid Beheshti Freeway Rasht Guilan Iran (Islamic Republic of)