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IRCT20160307026950N17 IRCT 2020-03-19 Esfahan University of Medical Sciences The Survey of Prophylaxic Two Different Doses of Dexmedetomidine in Prevention of Shivering During Regional Anesthesia in Cesarean Section Comparison of the Effectiveness of Prophylaxic Two Different Doses of Dexmedetomidine in Prevention of Shivering During Regional Anesthesia in Cesarean Section 2020-02-02 anticipated 60 Complete https://irct.ir/trial/45420 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to three groups A, B, C using the Random Allocation computer software, Blinding description: The drug and placebo are prepared in one form and in the form of a volume in the syringe by the researcher, and the hemodynamic changes are monitored and recorded, so the attending and the clinical caregiver and the evaluator and data analyser do not understand the type of medication and the investigator deciphers the codes after data analysis. 3 Shivering. Intervention 1: Intervention group A: informed consent from patients first. After patients are placed on operating room bed, standard monitoring including pulse oximeter, barometer, ECG and baseline vital signs Group A = 2.5 μg / kg intravenous dexmedetomidine Is given immediately after induction of anesthesia, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times. Intervention 2: Intervention groupB: informed consent from patients first. After patients are placed on operating room bed, standard monitoring including pulse oximeter, barometer, ECG and baseline vital signs Group A = 5μg / kg intravenous dexmedetomidine Is given immediately after induction of anesthesia, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times. Intervention 3: Control group: informed consent from patients is first obtained. After placing the patients on the operating room bed, standard monitoring including pulse oximeter, barometer, ECG and baseline vital signs are recorded. Intravenous saline is given immediately after induction of anesthesia and moderate arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired time. 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 Need to gather more information
public Samira Heydari
Valiasr Street
Khorzouq Iran (Islamic Republic of) 8345154611 +98 31 4540 6714 samiraheydari2525@yahoo.com Esfahan University of Medical Sciences scientific Behzad Nazemroaya
Hezarjarib Street
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) Iran (Islamic Republic of) Pregnant women in the age range18-45 2- Anesthesiologists American Society of (ASA)) degree2and3 candidate for cesarean section Patient consent to participate in the study 18 years 45 years Female A history of hypersensivity to alpha adrenergic drug Liver Patients Bradycardy history 2nd or 3nd degree AV block Vascular problems Type 2 diabetes Hyopvolemia Taking vasodilator or medications that change the body's central temperature Drug use Prevention Prevention Prevention Intervention group A: informed consent from patients first. After patients are placed on operating room bed, standard monitoring including pulse oximeter, barometer, ECG and baseline vital signs Group A = 2.5 μg / kg intravenous dexmedetomidine Is given immediately after induction of anesthesia, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times. Intervention groupB: informed consent from patients first. After patients are placed on operating room bed, standard monitoring including pulse oximeter, barometer, ECG and baseline vital signs Group A = 5μg / kg intravenous dexmedetomidine Is given immediately after induction of anesthesia, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times. Control group: informed consent from patients is first obtained. After placing the patients on the operating room bed, standard monitoring including pulse oximeter, barometer, ECG and baseline vital signs are recorded. Intravenous saline is given immediately after induction of anesthesia and moderate arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired time. Shivering. Timepoint: Recovery Duration. Method of measurement: Using the Grassi and Mahajan criterion. Central temprature. Timepoint: At he base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Tympanic thermometer. Temperature of Peripheral. Timepoint: At he base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Thermometer Skin. The level of sedation. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Using the Ramsay Sedation Scale. Severity of Pain. Timepoint: At of recovery. the base time; after the procedure and then every 15 minutes until discharge. Method of measurement: Using the Visual Analogue Scale. Systolic blood pressure. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Non invasive blood pressure measurement. Diastolic blood pressure. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Non invasive blood pressure measurement. Oxygen saturation. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Pulse oximetry device. Heart Rate. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Heart monitoring device. Mean Arterial Blood Pressure. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Non invasive blood pressure measurement. Duration of stay in recovery. Timepoint: From recovery admission to recovery discharge. Method of measurement: Watch or clock. Nausea. Timepoint: Duration of stay in recovery. Method of measurement: Questionnaire. Vomiting. Timepoint: Duration of stay in recovery. Method of measurement: Questionnaire. Itching. Timepoint: Duration of stay in recovery. Method of measurement: Questionnaire. Usage of Atropine. Timepoint: From the beginning of the opration to the end of recovery. Method of measurement: Anesthesia Technician Asked About Drug Use. Usage of Pethidine. Timepoint: Duration of stay in recovery. Method of measurement: Anesthesia Technician Asked About Drug Use. Usage of Ephedrine. Timepoint: From the beginning of the opration to the end of recovery. Method of measurement: Anesthesia Technician Asked About Drug Use. Isfahan University of Medical Sciences Approved 2020-02-01 Ethics committee of Isfahan University of Medical Sciences Hezar jarib Street Isfahan Isfehan Iran (Islamic Republic of)