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IRCT20110425006281N2 IRCT 2018-12-29 Rasht University of Medical Sciences Comparison of Ketamine, Tramadol, and Ondansetron in shiver controlling Comparison of the effectiveness of Ketamine, Tramadol and Ondansetron on prevention of shivering due to Spinal Anesthesia in cesarean section surgery 2018-11-22 anticipated 508 Complete https://irct.ir/trial/33951 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomized with quadruple blocks and divide into four groups of a low dose of ketamine=A, tramadol=B, Ondansetron=C, and control=D. The randomization unit is individual. In this randomization, we do not have a layer and we use a random numbers table tool. The method of constructing a random sequence is as follows: ABCD-ABDC-ACBD-ACDB-ADBC-ADCB-BACD-BADC-BDCA-BDAC-BCAD-BCDA--CABD-CADB-CBAD-CBDA-CDAB-CDBA-DABC-DACB-DCAB-DCBA-DBAC-DBCA-ABCD-ABDC-ACBD-ACDB-ADBC-ADCB-BACD-BADC-BDCA-BDAC-BCAD-BCDA-CABD-CADB-CBAD-CBDA-CDAB-CDBA-DABC-DACB-DCAB-DCBA-DBAC-DBCA-ABCD-ABDC-ACBD-ACDB-ADBC-ADCB-BACD-BADC-BDCA-BDAC-BCAD-BCDA-CABD-CADB-CBAD-CBDA-CDAB-CDBA-DABC-DACB-DCAB-DCBA-DBAC-DBCA-ABCD-ABDC-ACBD-ACDB-ADBC-ADCB-BACD-BADC-BDCA-BDAC-BCAD-BCDA--CABD-CADB-CBAD-CBDA-CDAB-CDBA-DABC-DACB-DCAB-DCBA-DBAC-DBCA-ABCD-ABDC-ACBD-ACDB-ADBC-ADCB-BACD-BADC-BDCA-BDAC-BCAD-BCDA-CABD-CADB-CBAD-CBDA-CDAB-CDBA-DABC-DACB-DCAB-DCBA-DBAC-DBCA-ABCD-ABDC-ACBD-ACDB-ADBC-ADCB-BACD After providing the list, we will give it to the anesthetic technician to categorize patients in control or treatment groups based on the above list, Blinding description: All drugs and placebo (normal saline) are prepared by an anesthetic technician who is not included in this study and will be coded in 5-millimeter syringes and will be given to the responsible anesthetist. So, In the event of complications (drowsiness, nausea, vomiting, itching, flushing, and hallucination), it will be clear which patient belongs to which Group and if necessary, it will be treated based on the type of complication. Accordingly, patients, the anesthetist, and the trained person recording items listed in the questionnaire (severity of shivering, Apgar minute one and five and vital signs of patients) are unaware of the type of treatment group. 3 Shivering Complication in Spinal Anesthesia in Cesarean Section. Intervention 1: Intervention group: low dose of ketamine (0.2 milligrams per Kilogram intravenous), (500 milligrams per 10 milliliters of the Stroup pharmaceutical company in Belgium). Immediately after spinal anesthesia, it will be injected to patients. Intervention 2: Intervention group Tramadol (0.5 milligrams per Kilogram intravenous), (50 milligrams per milliliters, Drugpakhsh Pharmaceutical Company). Immediately after spinal anesthesia, it will be injected to patients. Intervention 3: Intervention group Ondansetron (4 milligrams intravenous), (4 milligrams in 2 milliliters produced by Borujerd-Iran General Purpose Pharmacy Company).Immediately after spinal anesthesia, it will be injected to patients. Intervention 4: Control group: 5 milliliters of normal saline will be injected to patients, immediately after spinal anesthesia. 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 not decided yet
public Dr Ali Mohammadzadeh Joryabi
Heshmat Hospital
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3366 9066 alimj1393@gmail.com Rasht University of Medical Sciences scientific Dr Ali Mohammadzadeh Joryabi
Heshmat Hospital
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3366 9066 alimj1393@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Pregnant women Candidates for cesarean section Under spinal anesthesia ASA class I, II Age between 18-39 18 years 39 years Female History of allergy Prohibition for each of the studied drugs Addiction to any chemical or natural compound Psychosis Having cold Heart disease Liver and kidney dysfunction History of seizure History of using Monoamine Oxidase inhibitor in the past 14 days Severe asthma Respiratory depression The initial temperature of the patient`s body is above 38 Celsius or the central temperature is less than 36 Celsius Getting any medication that changes the thermoregulation Weight over 100 Kilograms and below 50 Kilograms History of using vasodilator Cases requiring sedation or having intravenous administration due to partial spinal anesthetics A condition that temperature cannot be maintained due to equipment problems in heating and cooling systems O74.6 Other complications of spinal and epidural anesthesia during labor and delivery Prevention Prevention Prevention Prevention Intervention group: low dose of ketamine (0.2 milligrams per Kilogram intravenous), (500 milligrams per 10 milliliters of the Stroup pharmaceutical company in Belgium). Immediately after spinal anesthesia, it will be injected to patients. Intervention group Tramadol (0.5 milligrams per Kilogram intravenous), (50 milligrams per milliliters, Drugpakhsh Pharmaceutical Company). Immediately after spinal anesthesia, it will be injected to patients. Intervention group Ondansetron (4 milligrams intravenous), (4 milligrams in 2 milliliters produced by Borujerd-Iran General Purpose Pharmacy Company).Immediately after spinal anesthesia, it will be injected to patients. Control group: 5 milliliters of normal saline will be injected to patients, immediately after spinal anesthesia. Severity of shivering. Timepoint: Every 5 minutes during surgery and every 15 minutes in 45 minutes of recovery time, the intensity of shivering will be recorded. Method of measurement: Shivering classification table. Baby`s Apgar Minute One and five. Timepoint: Minute one and five of baby's birth. Method of measurement: Based on Apgar Assessment Table. Rasht University of Medical Sciences Approved 2018-09-01 Ethics Committee Of Guilan University Of Medical Sciences Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street Rasht Guilan Iran (Islamic Republic of)