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IRCT20120915010841N27 IRCT 2022-09-03 Hamedan University of Medical Sciences postoperative shivering Comparison of intravenous Dexmedetomidine and Meperidine in the treatment of post spinal shivering in cesarean section 2022-09-23 anticipated 246 Complete https://irct.ir/trial/64751 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the quadruple Block Randomization method. For this purpose, we prepare four sheets of paper.Write the letter A on two sheets and the letter B on the other two sheets. Mix the sheets together and place them in the desk drawer. With the referral of each eligible patient, one of the sheets is randomly taken out and based on this sheet is A or B, it will be assigned to one of the two groups of Dexmedetomidine and Meperidine. After randomly pulling out all four sheets, all the papers are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size is reached, Blinding description: After spinal anesthesia and the start of surgery and delivery of the baby, if the patient experiences shivering, she will receive one of the drugs Dexmedomidine and Meperidine,which is prepared in syringes with the same size and shape and labeled A and B by the nurse of anesthesia who is not involved in collecting or recording data. 2-3 Treatment of intra or postoperative shivering. Intervention 1: Intervention group: After spinal anesthesia and ensuring sensory block at the T4 level, all patients will be prepped and covered with a double layer of surgical drapes and the surgery will begin. During surgery and recovery, patients will be checked for shivering. In case of shivering in group A , patients will receive meperidine 0.5mg/kg after umbilical cord clamping with a total volume of 20ml within 10 minutes . Intervention 2: Intervention group: After spinal anesthesia and ensuring sensory block at the T4 level, all patients will be prepped and covered with a double layer of surgical drapes and the surgery will begin. During surgery and recovery, patients will be checked for shivering. In case of shivering in group B , patients will receive dexmedetomidine 0.5ug/kg after umbilical cord clamping with a total volume of 20ml within 10 minutes . 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 Because the study is not finished yet.
public Nahid Manouchehrian
Fatemieh Hospital, Pasdaran Street
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences scientific Nahid Manouchehrian
Fatemieh Hospital, Pasdaran Street.
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Conscious consent to participate in the study Parturients candidate for cesarean section under spinal anesthesia 18 to 46 years old Patients with shivering during surgery or in recovery with a grade of more than 2 18 years 46 years Female Withdrawal from participation of the study Cardiac and pulmonary, hepatic, renal diseases, hypertension, diabetes, arrhythmia and heart failure Eclampsia and preeclampsia Contraindications of spinal anesthesia (high ICP, hypovolemia, anemia, coagulation disorders) History of seizures or Parkinson's disease Intraoperative transfusion History of taking sedative-hypnotic and vasodilator drugs Dysautonomia Allergy to the drugs O74.6 Other complications of spinal and epidural anaesthesia during labour and delivery Treatment - Drugs Treatment - Drugs Intervention group: After spinal anesthesia and ensuring sensory block at the T4 level, all patients will be prepped and covered with a double layer of surgical drapes and the surgery will begin. During surgery and recovery, patients will be checked for shivering. In case of shivering in group A , patients will receive meperidine 0.5mg/kg after umbilical cord clamping with a total volume of 20ml within 10 minutes . Intervention group: After spinal anesthesia and ensuring sensory block at the T4 level, all patients will be prepped and covered with a double layer of surgical drapes and the surgery will begin. During surgery and recovery, patients will be checked for shivering. In case of shivering in group B , patients will receive dexmedetomidine 0.5ug/kg after umbilical cord clamping with a total volume of 20ml within 10 minutes . Shivering intensity. Timepoint: In 5,10,15 and 20 minutes after the administration of meperidine and dexmedomidine drugs. Method of measurement: Observation based on crossley score of shivering. Systolic and diastolic blood pressure. Timepoint: Before injection and in 5,10,15,20 and 30 minutes after the administration of shivering drugs. Method of measurement: Non-invasive automatic barometric device. Heart Rate. Timepoint: Before injection and in 5,10,15,20 and 30 minutes after the administration of shivering drugs. Method of measurement: Pulse oximetry. Percentage of arterial oxygen saturation. Timepoint: Before injection and in 5,10,15,20 and 30 minutes after the administration of shivering drugs. Method of measurement: Pulse oximetry. Nausea & vomiting. Timepoint: After the injection of drugs for the treatment of shivering until the patient leaves the operating room. Method of measurement: Observation. Sedation score. Timepoint: Before injection and in 5,10,15,20 and 30 minutes after the administration of shivering drugs. Method of measurement: Ramsy sedation score. Dizziness. Timepoint: After the injection of drugs for the treatment of shivering until the patient leaves the operating room. Method of measurement: Question from the patient. Hamedan University of Medical Sciences Approved 2022-07-23 Ethics committee of Hamadan University of Medical Sciences Mahdieh Street Hamadan Hamadan Iran (Islamic Republic of)