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IRCT20110528006617N5 IRCT 2021-01-30 Esfahan university of medical sciences The effect of dexmedtomidine and fentanyl on hemodynamic indicies in Stereotaxic surgeries. Comparison effect of fentanyl and dexmedtomidine on hemodynamic changes during stereotaxic surgeries 2017-03-21 anticipated 68 Complete https://irct.ir/trial/39369 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random function "Random Number Generation " of Excel software based on patient file number will be used for randomization. Patients file number were entered into Excel program and patients were divided into case and control groups based on the random button. In total, there were two groups of 68 people. In this case, the file number is entered in Excel program, then a random number is selected from the data analysis command. This study has 2 groups that can be numbered from 1 to 2, respectively. We also want 34 people in each group. As a result, sequences 1 to 2 should be repeated 34 times each time. It is clear that the repetition of each number occurs once in each group, so select 1 for repeating each number and 34 for repeating the sequence. In this way, 68 units will be produced, Blinding description: Patient information is hidden by the operating room nurse and injectable drugs are also provided to the physician in similar syringes by an anesthetic technician, while the physician will not have any knowledge concerning the substance in the syringe. In addition, the participants will not be informed about the injectable drugs in each syringe and the names of the operating room personnel. 2-3 General Anesthesia. Intervention 1: The first intervention group: Initially,personal consent is obtained from the patients.Then the patient is placed on the perating bed and standard monitoring devices including pulsoximetry,capnography are attached .Then 2 micrigram per kilogram fentanyl is injected. Intervention 2: The second intervention group: Initially,personal consent is obtained from the patients.Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry,capnography are attached .Then 1 micrigram per kilogram dexmedtomidine is infused in 10 minutes and then 0.5 microgram per kilogram per hour dexmedtomidine 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 There is no further information
public Mina Foroughi
No.35 , Allahoakbar Ave., Jey Street
Isfahan Iran (Islamic Republic of) 8159665399 +98 31 3528 4210 Mina.f1994@gmail.com Esfahan University of Medical Sciences scientific Mehrdad Masoudifar
Hezar jarib Street
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 Masoudifar@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age btween 18-65 years old Patients who consent to the informed consent to participate in the study. Patient with american society of anesthesiology physical status class 1,2(ASA I,II) 18 years 65 years Both Patients who have bradycardia and heart block. Patients who have anticoagulant drugs. Patients who have drugs affect on hemodynamic status. T88.5 Other complications of anesthesia Treatment - Drugs Treatment - Drugs The first intervention group: Initially,personal consent is obtained from the patients.Then the patient is placed on the perating bed and standard monitoring devices including pulsoximetry,capnography are attached .Then 2 micrigram per kilogram fentanyl is injected. The second intervention group: Initially,personal consent is obtained from the patients.Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry,capnography are attached .Then 1 micrigram per kilogram dexmedtomidine is infused in 10 minutes and then 0.5 microgram per kilogram per hour dexmedtomidine is infused. Systolic blood pessure. Timepoint: Before intervention and 30,60,90,120 minutes after intervention and recovery time. Method of measurement: Mm-hg, sphygmomanometer. Diastolic blood pressure. Timepoint: Before intervention and 30,60,90,120 minutes after intervention and recovery time. Method of measurement: Mm-hg, sphygmomanometer. Heart rate. Timepoint: Before intervention and 30,60,90,120 minutes after intervention and recovery time. Method of measurement: ECG monitor. Mean arterial pressure. Timepoint: Before intervention and 30,60,90,120 minutes after intervention and recovery time. Method of measurement: Mm-hg, sphygmomanometer. O2 saturation. Timepoint: Before intervention and 30,60,90,120 minutes after intervention and recovery time. Method of measurement: O2 saturation percentage , pulse oximeter device. Esfahan university of medical sciences Approved 2017-09-27 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave Isfahan Isfehan Iran (Islamic Republic of)