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IRCT20090129001615N7 IRCT 2023-05-13 Esfahan University of Medical Sciences Investigating the preemptive effect of two different doses of dexmedetomidine on changes in blood pressure and heart rate following the use of a tourniquet during a randomized trial of upper extremity orthopedic surgery Investigating the preemptive effect of two different doses of dexmedetomidine on changes in blood pressure and heart rate following the use of a tourniquet during a randomized trial of upper extremity orthopedic surgery 2023-05-21 anticipated 90 Complete https://irct.ir/trial/69792 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: It will be done using Random Allocation software. Patients are placed in three groups of 30, dexmedetomidine 1 and 2 and saline (control) group, Blinding description: The patient and the person collecting the study data are not aware of the study group. The statistician who analyzes the data will also include this requirement. 3 Condition 1: Blood pressure. Condition 2: Heart rate. Intervention 1: Intervention group one: In the dexmedetomidine 1 group, 1 (kg/µg) dexmedetomidine is infused within 10 minutes and then continued with a dose of 0.75 (kg/µg) dexmedetomidine infusion during the operation. Intervention 2: Intervention group two: In the dexmedetomidine group 2, 1 (kg/µg) dexmedetomidine is infused within 10 minutes and then continued with a dose of 1 (kg/µg) dexmedetomidine infusion during the operation. Intervention 3: Control group: In the control group, normal saline is infused. 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 No further information is available
public Azim Honarmand
Hezar Jerib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 110 2327 honarmand@med.mui.ac.ir Esfahan University of Medical Sciences scientific Azim Honarmand
Hezar Jerib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 110 2327 honarmand@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with ASA (American Society of Anesthesiologists) = 1, aged 18-65 years, who are Patients aged 18-65 years Candidates for upper limb orthopedic surgery under tourniquet who undergo general anesthesia 18 years 65 years Both Addicted people People with a history of allergy to the studied drugs People with heart, liver or kidney failure People with ASA = 2 Prevention Prevention Placebo Intervention group one: In the dexmedetomidine 1 group, 1 (kg/µg) dexmedetomidine is infused within 10 minutes and then continued with a dose of 0.75 (kg/µg) dexmedetomidine infusion during the operation. Intervention group two: In the dexmedetomidine group 2, 1 (kg/µg) dexmedetomidine is infused within 10 minutes and then continued with a dose of 1 (kg/µg) dexmedetomidine infusion during the operation. Control group: In the control group, normal saline is infused. Blood pressure. Timepoint: At baseline times (before administration of study drugs) and then at times 0, 10, 20, 30, 40, 50 and 60 minutes after tourniquet inflation and then immediately after deflation. Method of measurement: Sphygmomanometer. Heart rate. Timepoint: At baseline times (before administration of study drugs) and then at times 0, 10, 20, 30, 40, 50 and 60 minutes after tourniquet inflation and then immediately after deflation. Method of measurement: Electrocardiogram. Oxygen saturation. Timepoint: At baseline times (before administration of study drugs) and then at times 0, 10, 20, 30, 40, 50 and 60 minutes after tourniquet inflation and then immediately after deflation. Method of measurement: Pulse oximeter. Esfahan University of Medical Sciences Approved 2023-03-14 Ethics Committee of Isfahan University of Medical Sciences Soffeh st. Isfahan Isfehan Iran (Islamic Republic of)