]>
IRCT20160307026950N18 IRCT 2020-04-01 Esfahan University of Medical Sciences The investigation of effects of dexmedetomedine, ondansetron and pethidin on postoperative shivering Comparison of the prophylactic effects of intravenous injection of Dexmedetomidine, Ondansetron, and pethidine on postoperative shivering of abdominal surgery under general anesthesia 2020-09-22 anticipated 128 Complete https://irct.ir/trial/45602 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling will be done by the simple method and patients depending on the time of entry who meet the necessary conditions entered into the study in order to reach the sample size. Also, patients will be distributed in a randomized block allocation method and with the required number among the groups, Blinding description: The method of blinding is that patients are unaware of the type of drug they are given and also drugs and placebo provided in similar syringes and coded for those by the researcher and given to the study expert to inject. and the hemodynamic changes are monitored and recorded, so the attending and the clinical caregiver and the examiner and data analyzer will not understand the type of medication and the investigator deciphers the codes after data analysis. 3 postoperative shivering. Intervention 1: Intervention group D: First the written consent will be obtained from patients. after placing the patients on the bed, standard monitoring will be applied (including a pulse oximeter, capnograph, Manometer,ECG and basic vital signs ). for Group D: 0.5 μg /kg intravenous Dexmedetomidine will be injected after discontinuation the anesthetic drug, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times. Intervention 2: Intervention group P: First the written consent will be obtained from patients. after placing the patients on the bed, standard monitoring devices will be applied (including a pulse oximeter, capnograph, Manometer,ECG and basic vital signs ). for group P: 0.5 mg/kg Pethidine will be injected after discontinuing the anesthetic drug, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times. Intervention 3: Intervention group O: First the written consent will beobtained from patients. after placing the patients on the bed, standard monitoring devices will be applied (including a pulse oximeter, capnograph, Manometer,ECG and basic vital signs ). for group O; 0.1 mg/kg Ondansetron will be injected after discontinuing the anesthetic drug, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times. Intervention 4: Control group N; First the written consent will be obtained from patients. after placing the patients on the bed, standard monitoring devices will be applied (including a pulse oximeter, capnograph, Manometer,ECG and basic vital signs ). for group N, distilled wate will be injected after discontinuing the anesthetic drug, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times. 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 Mahsa Heydari
Esfahan University of Medical Sciences,Hezar Jarib Ave
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 heydari72.mahsa@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazemroaya
Hezarjarib Street
Esfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) ASA class I and II Candidate for abdominal surgery under general anesthesia The range from 18-60 years of age The patient's consent to participate in the study 18 years 60 years Both A History of TCA, MAOI, vasoactive agent, painkiller and opiate medication Musculoskeletal and nervous system diseases, thyroid diseases Dysautonomia, fever, pregnancy, obesity(BMI>27) The history of cardiovascular, respiratory, enocrin or neurologic diseases Allergic to sulfate of magnesium, ketamine and pethidin Prevention Prevention Prevention Placebo Intervention group D: First the written consent will be obtained from patients. after placing the patients on the bed, standard monitoring will be applied (including a pulse oximeter, capnograph, Manometer,ECG and basic vital signs ). for Group D: 0.5 μg /kg intravenous Dexmedetomidine will be injected after discontinuation the anesthetic drug, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times. Intervention group P: First the written consent will be obtained from patients. after placing the patients on the bed, standard monitoring devices will be applied (including a pulse oximeter, capnograph, Manometer,ECG and basic vital signs ). for group P: 0.5 mg/kg Pethidine will be injected after discontinuing the anesthetic drug, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times. Intervention group O: First the written consent will beobtained from patients. after placing the patients on the bed, standard monitoring devices will be applied (including a pulse oximeter, capnograph, Manometer,ECG and basic vital signs ). for group O; 0.1 mg/kg Ondansetron will be injected after discontinuing the anesthetic drug, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times. Control group N; First the written consent will be obtained from patients. after placing the patients on the bed, standard monitoring devices will be applied (including a pulse oximeter, capnograph, Manometer,ECG and basic vital signs ). for group N, distilled wate will be injected after discontinuing the anesthetic drug, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times. Shivering. Timepoint: On arrival to the recovery room and then every 15 minutes for one hour. Method of measurement: Shivering severity is assessed by Crassly and Mahajan Score. Central temperature. Timepoint: Before surgery, before drug administration, after intubation, every 15 minutes during the anesthesia, at the end of anesthesia, after extubation, on arrival to the recovery room and then every 15 minutes for one hour. Method of measurement: Tympanic thermometer. Peripheral temperature. Timepoint: Before surgery, before drug administration, after intubation, every 15 minutes during the anesthesia, at the end of anesthesia, after extubation, on arrival to the recovery room and then every 15 minutes for one hour. Method of measurement: Thermometer. 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 the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Using the Visual Analogue Scale. Systolic blood pressure. Timepoint: Before surgery, every 15 minutes during the anesthesia, on arrival to the recovery room and then every 15 minutes. Method of measurement: Non invasive manometer. Diastolic blood pressure. Timepoint: Before surgery, every 15 minutes during the anesthesia, on arrival to the recovery room and then every 15 minutes. Method of measurement: Non invasive manometer. Oxygen saturation. Timepoint: since entering the operating room until leaving the recovery room. Method of measurement: Pulse oximeter. Heart rate. Timepoint: since entering the operating room until leaving the recovery room. Method of measurement: Heart monitoring device. Mean Arterial Blood Pressure. Timepoint: Before surgery, every 15 minutes during the anesthesia, on arrival to the recovery room and then every 15 minutes. Method of measurement: Non invasive blood pressure measurement. Recovery length. Timepoint: On arrival to the recovery room and then every 15 minutes till recovery room. Method of measurement: Watch or clock. Nausea. Timepoint: Recovery length. Method of measurement: Questioning. Vomiting. Timepoint: Recovery length. Method of measurement: Observing. Itching. Timepoint: Recovery length. Method of measurement: Questioning. Atropine taken dose. Timepoint: Since the beginning of the operation until the end of the recovery length. Method of measurement: Asking from the anesthesia technician. Pethidine taken dose. Timepoint: Since the beginning of the operation until the end of the recovery length. Method of measurement: Asking from the anesthesia technician. Ephedrine taken dose. Timepoint: Since the beginning of the operation until the end of the recovery length. Method of measurement: Asking from the anesthesia technician. Isfahan University of Medical Sciences Approved 2019-06-30 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)