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IRCT20160307026950N46 IRCT 2022-09-24 Esfahan University of Medical Sciences Comparison of hemodynamic changes caused by induction of anesthesia with Ketamine-Propofol and Etomidate Comparison of hemodynamic changes caused by induction of anesthesia with Ketamine-Propofol, and Etomidate in patients over 65 years old 2022-09-23 anticipated 90 Complete https://irct.ir/trial/65638 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Randomization will be done by the simple method in which each patient will be assigned a code using a random number table (Random allocation software) and Patients fall into one of two groups depending on whether these codes are even or odd. This continues until the number of patients in both groups reaches the required number, Blinding description: This is a triple blind clinical trial; In this way, the patient is included in the study but does not know the type of intervention applied and is blind, the researcher who records the patient's symptoms is also different from the person who injects the drug and without knowing the type of drug only records the patient's symptoms during the study and therefore is kept blind. The analysts who analyze the data collected during the study also do not know the type of intervention applied in each group and are blind. 3 Hemodynamic changes in anesthesia induction. Intervention 1: Intervention group A: Patients in this group received 2 Micrograms/kg of fentanyl manufactured by Aburihan Pharmaceutical Company and 2mg of intravenous Midazolam manufactured by Elixir Pharmaceutical Company after connecting the monitoring devices and preparing vital sign recording devices. Then 0.6mg/kg Atracurium was manufactured by Caspian Pharmaceutical Company and 1.5mg/kg Lidocaine was manufactured by Caspian Pharmaceutical Company as well as 0.3mg/kg Etomidate was manufactured by Ayman Sahar Pharmaceutical Company at a rate of 0.1mg/kg/min for induction of anesthesia and after About three minutes of ventilation with a face mask, tracheal intubation is performed, and the patient's symptoms are measured and recorded. Intervention 2: Intervention group B: Patients in this group received 2 Micrograms/kg of fentanyl manufactured by Aburihan Pharmaceutical Company and 2mg of intravenous Midazolam manufactured by Elixir Pharmaceutical Company after connecting the monitoring and preparing vital sign recording devices. Then 0.6mg/kg of Atracurium manufactured by Caspian Pharmaceutical Company and 1.5mg/kg of Lidocaine manufactured by Caspian Pharmaceutical Company and also 1.5mg/kg of Propofol produced by Darman Yab Daro Company at a speed of 0.5cc/s and 0.5mg/kg of Ketamine produced by Darman Yab Daro Company. are given at a rate of 0.5 mg/kg/min to induce anesthesia, and after about three minutes of ventilation with a face mask, tracheal intubation is performed and the patient's symptoms are measured and recorded. 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 Marzieh Soheyli Pur
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 Msoheili8896@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazem roaya
Hezar Jarib
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) Patients over 65 years old Candidate for elective surgery under general anesthesia Anesthesia class I and II according to ASA criteria Informed consent to enter the study 65 years no limit Both History of drug, alcohol and Benzodiazepine use BMI (Body Mass Index)>30 History of seizures Adrenal gland failure High Blood Pressure Candidate for Craniotomy surgery Diagnosis Diagnosis Intervention group A: Patients in this group received 2 Micrograms/kg of fentanyl manufactured by Aburihan Pharmaceutical Company and 2mg of intravenous Midazolam manufactured by Elixir Pharmaceutical Company after connecting the monitoring devices and preparing vital sign recording devices. Then 0.6mg/kg Atracurium was manufactured by Caspian Pharmaceutical Company and 1.5mg/kg Lidocaine was manufactured by Caspian Pharmaceutical Company as well as 0.3mg/kg Etomidate was manufactured by Ayman Sahar Pharmaceutical Company at a rate of 0.1mg/kg/min for induction of anesthesia and after About three minutes of ventilation with a face mask, tracheal intubation is performed, and the patient's symptoms are measured and recorded. Intervention group B: Patients in this group received 2 Micrograms/kg of fentanyl manufactured by Aburihan Pharmaceutical Company and 2mg of intravenous Midazolam manufactured by Elixir Pharmaceutical Company after connecting the monitoring and preparing vital sign recording devices. Then 0.6mg/kg of Atracurium manufactured by Caspian Pharmaceutical Company and 1.5mg/kg of Lidocaine manufactured by Caspian Pharmaceutical Company and also 1.5mg/kg of Propofol produced by Darman Yab Daro Company at a speed of 0.5cc/s and 0.5mg/kg of Ketamine produced by Darman Yab Daro Company. are given at a rate of 0.5 mg/kg/min to induce anesthesia, and after about three minutes of ventilation with a face mask, tracheal intubation is performed and the patient's symptoms are measured and recorded. Blood Pressure. Timepoint: before induction of anesthesia, after induction of anesthesia, before laryngoscopy, 1, 3, 5 and 10 minutes after laryngoscopy. Method of measurement: Sphygmomanometer. Heart Rate. Timepoint: before induction of anesthesia, after induction of anesthesia, before laryngoscopy, 1, 3, 5 and 10 minutes after laryngoscopy. Method of measurement: Electrocardiogram. O2 Saturation. Timepoint: before induction of anesthesia, after induction of anesthesia, before laryngoscopy, 1, 3, 5 and 10 minutes after laryngoscopy. Method of measurement: Pulse Oximeter. Esfahan University of Medical Sciences Approved 2022-07-19 Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)