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IRCT20200825048515N20 IRCT 2021-01-03 Esfahan University of Medical Sciences The effect of remifentanil intranasal on hemodynamic changes induced by electroconvulsive therapy Evaluation of the effect of different doses of remifentanil intranasal on hemodynamic changes induced by electroconvulsive therapy 2021-01-04 anticipated 80 Complete https://irct.ir/trial/53179 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 80 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups, Blinding description: In order to achieve the double-blind study, different doses of remifentanil and placebo (without remifentanil) will be prepared daily by the nurse of the electroshock ward (without the researcher's awareness) and placed in the bag and will be labeled A, B, C and D. And is given daily to the anesthesiologist (researcher). Therefore, the patient will not be aware of the type of medicine he/she is receiving. 3 Electroshock therapy. Intervention 1: Intervention group 1: Prior to electroconvulsive therapy, patients receive remifentanil at a dose of 0.25 mg/kg intranasally in both nostrils. One minute after the intervention, anesthetic induction drugs including midazolam, thiopental sodium, and succinylcholine are injected based on the patient's weight. Patients receive electroconvulsive therapy 30 to 45 seconds after receiving succinylcholine. Intervention 2: Intervention group 2: Prior to electroconvulsive therapy, patients receive remifentanil at a dose of 0.5 mg/kg intranasally in both nostrils. One minute after the intervention, anesthetic induction drugs including midazolam, thiopental sodium, and succinylcholine are injected based on the patient's weight. Patients receive electroconvulsive therapy 30 to 45 seconds after receiving succinylcholine. Intervention 3: Intervention group 3: Prior to electroconvulsive therapy, patients receive remifentanil at a dose of 0.75 mg/kg intranasally in both nostrils. One minute after the intervention, anesthetic induction drugs including midazolam, thiopental sodium, and succinylcholine are injected based on the patient's weight. Patients receive electroconvulsive therapy 30 to 45 seconds after receiving succinylcholine. Intervention 4: Control group: Prior to electroconvulsive therapy, patients receive a placebo intranasally in both nostrils. One minute after the intervention, anesthetic induction drugs including midazolam, thiopental sodium, and succinylcholine are injected based on the patient's weight. Patients receive shock therapy 30 to 45 seconds after receiving succinylcholine. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Behzad Nazemroaya
Anesthesiology Department, Al-Zahra Hospital, Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences scientific Behzad Nazemroaya
Anesthesiology Department, Al-Zahra Hospital, Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Aged over 18 years Candidates for electroconvulsive therapy for the first time Classified as ASA I based on American Society of Anesthesiologists Classification No fever Consent to participate in the study 18 years no limit Both Allergy to remifentanil History of nasal-related diseases that interfere with intranasal drug administration Y84.3 Shock therapy as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Prior to electroconvulsive therapy, patients receive remifentanil at a dose of 0.25 mg/kg intranasally in both nostrils. One minute after the intervention, anesthetic induction drugs including midazolam, thiopental sodium, and succinylcholine are injected based on the patient's weight. Patients receive electroconvulsive therapy 30 to 45 seconds after receiving succinylcholine. Intervention group 2: Prior to electroconvulsive therapy, patients receive remifentanil at a dose of 0.5 mg/kg intranasally in both nostrils. One minute after the intervention, anesthetic induction drugs including midazolam, thiopental sodium, and succinylcholine are injected based on the patient's weight. Patients receive electroconvulsive therapy 30 to 45 seconds after receiving succinylcholine. Intervention group 3: Prior to electroconvulsive therapy, patients receive remifentanil at a dose of 0.75 mg/kg intranasally in both nostrils. One minute after the intervention, anesthetic induction drugs including midazolam, thiopental sodium, and succinylcholine are injected based on the patient's weight. Patients receive electroconvulsive therapy 30 to 45 seconds after receiving succinylcholine. Control group: Prior to electroconvulsive therapy, patients receive a placebo intranasally in both nostrils. One minute after the intervention, anesthetic induction drugs including midazolam, thiopental sodium, and succinylcholine are injected based on the patient's weight. Patients receive shock therapy 30 to 45 seconds after receiving succinylcholine. Blood pressure. Timepoint: 1, 5, 10, and 20 minutes after the end of the convulsion. Method of measurement: Monitoring device. Heart rate. Timepoint: 1, 5, 10, and 20 minutes after the end of the convulsion. Method of measurement: Monitoring device. Oxygen saturation. Timepoint: 1, 5, 10, and 20 minutes after the end of the convulsion. Method of measurement: Monitoring device. Duration of convulsion. Timepoint: 1, 5, 10, and 20 minutes after the end of the convulsion. Method of measurement: Monitoring device. Isfahan University of Medical Sciences Approved 2020-06-23 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)