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IRCT20170516033992N10 IRCT 2022-04-12 Oroumia University of Medical Sciences The effect of granisetron and meperidine on shivering after elective cesarean A Comparison of the prophylactic effect of granisetron and meperidine on reducing shivering after elective cesarean under spinal anesthesia 2022-05-22 anticipated 100 Complete https://irct.ir/trial/62834 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups and the total number of the sample size will be entered, and then in the block section, the Block randomization method will be selected. Patients will be allocated to groups based on generated numbers, Blinding description: The study will be conducted as a double-blind clinical trial. The patient and the researcher who will be evaluating the outcomes will be blind to the allocation of patients into granisetron or meperidine groups. Group names will be encoded with the letters A and B. 3 Shivering after elective cesarean section with spinal anesthesia. Intervention 1: Intervention group: The spinal anesthesia will be performed using a standard 25 Quincke needle at L3-4 with hyperbaric 0.5 % bupivacaine 10 mg. Then, after the baby is born, patients will be injected with 0.4 mg/kg granisetron (group A). Intervention 2: Intervention group: The spinal anesthesia will be performed using a standard 25 Quincke needle at L3-4 with hyperbaric 0.5 % bupivacaine 10 mg. Then, after the baby is born, patients will be injected with 0.4 mg/kg meperidine (group B). No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patient information
public Dr. Tohid Karami
Mahzad hospital, Hassani Ave, Urmia, Iran.
Urmia Iran (Islamic Republic of) 5715859497 +98 44 3346 5079 karami.t@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Tohid Karami
Mahzad hospital, Hassani Ave, Urmia, Iran.
Urmia Iran (Islamic Republic of) 57159859497 +98 44 3346 5079 karami.t@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients undergoing elective cesarean section with spinal anesthesia Age between 20 to 40 years Patients with physical status one and two according to the criteria of the American Anesthesia Association (ASA I, II) Women with full-term pregnancy (more than 37 weeks) 20 years 40 years Female Chronic diseases Hypertension Diabetes Psychological disorders Drug allergy Cesarean section more than an hour JB22.0 Delivery by elective caesarean section Treatment - Other Treatment - Other Intervention group: The spinal anesthesia will be performed using a standard 25 Quincke needle at L3-4 with hyperbaric 0.5 % bupivacaine 10 mg. Then, after the baby is born, patients will be injected with 0.4 mg/kg granisetron (group A). Intervention group: The spinal anesthesia will be performed using a standard 25 Quincke needle at L3-4 with hyperbaric 0.5 % bupivacaine 10 mg. Then, after the baby is born, patients will be injected with 0.4 mg/kg meperidine (group B). Shivering. Timepoint: Every 5 minutes after surgery. Method of measurement: Clinical examination. Mean arterial pressure (MAP). Timepoint: Before, during and every 5 minutes after surgery. Method of measurement: Monitoring. Heart rate. Timepoint: Before, during and every 5 minutes after surgery. Method of measurement: Monitoring. Percentage of arterial blood oxygen saturation. Timepoint: Before, during and every 5 minutes after surgery. Method of measurement: Monitoring. Oroumia University of Medical Sciences Approved 2022-03-02 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)