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IRCT20160307026950N23 IRCT 2020-09-14 Esfahan University of Medical Sciences The effect of the combination of Ketamine and Midazolam as well as a combination of ketamine and dexmedetomidine in Electroshock therapy Comparison of the effect of low dose Ketamine and Midazolam injection with low dose Ketamine and Dexmedetomidine on changes in heart rate and blood pressure in Electroconvulsive therapy 2020-09-22 anticipated 70 Complete https://irct.ir/trial/50890 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization is a simple method; In this way, the first patient is assigned to one of the groups by lottery and the next patients are distributed consecutively and one in between in two groups so that the sample size reaches the required number in each group, Blinding description: The method of blinding is that patients are unaware of the type of drug received and also the executor of the project will be unaware of the type of injectable drug to patients. In this way, the drugs are prepared and coded in similar syringes by one of the operating room personnel who is not in the process of study, and are given to the executor for injection. 2 ElectroConvulsive Therapy. Intervention 1: Intervention group A: The patient will receive 0.1 mg / kg of Ketamine and 0.04 mg / kg of Midazolam. Intervention 2: Intervention group B: The patient will receive 0.1 mg per kg bodyweight of Ketamine and 0.5 micrograms per kg body weight of Dexmedetomidine. 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 There is no more information
public Zahra Manian
Hezar Jarib St.
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 Zahra.maniann@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazem roaya
Hezarjarib St
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Candidate patients for Electroconvulsive Therapy Age 18 to 65 Patient consent to study 18 years 65 years Both History of drug allergy History of cardiovascular disease Treatment - Drugs Treatment - Drugs Intervention group A: The patient will receive 0.1 mg / kg of Ketamine and 0.04 mg / kg of Midazolam. Intervention group B: The patient will receive 0.1 mg per kg bodyweight of Ketamine and 0.5 micrograms per kg body weight of Dexmedetomidine Heart Rate. Timepoint: Before drug injection, after drug injection, after shock termination, 5 and 10 minutes after end of seizure. Method of measurement: ECG monitoring. Blood Pressure. Timepoint: Before drug injection, after drug injection, after shock termination, 5 and 10 minutes after end of seizure. Method of measurement: Non-invasive blood pressure measurement. Oxygen Saturation. Timepoint: Before drug injection, after drug injection, after shock termination, 5 and 10 minutes after end of seizure. Method of measurement: Pulse Oxymeter. Duration of seizures. Timepoint: From the beginning to the end of the seizure. Method of measurement: Chronometer. Complications after anesthesia. Timepoint: From the time of drug discontinuation to the end of recovery. Method of measurement: View patient status. Recovery time. Timepoint: From stopping the drug to full consciousness. Method of measurement: Chronometer. Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2020-05-27 Ethics committee of Isfahan University of Medical Sciences Hezar jarib street Esfahan Isfehan Iran (Islamic Republic of)