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IRCT20230713058769N1 IRCT 2023-07-29 Arak University of Medical Sciences Comparison of the effect of ephedrine, ketamine, ondansetron and atropine drugs to prevent nausea and vomiting during and after surgery in patients under spinal anesthesia Comparison of the effect of ephedrine, ketamine, ondansetron and atropine drugs to prevent nausea and vomiting during and after surgery in patients under spinal anesthesia for lower limb fracture repair 2023-09-23 anticipated 128 Complete https://irct.ir/trial/71298 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be divided into 4 groups based on the balanced block randomization pattern and the size of the blocks will be 8. The randomization is done by the consultant professor using the online program at https://www.sealedenvelope.com/. Hiding the random chain is done by the method of opaque envelopes, Blinding description: The study will be designed in a double-blind manner. The method of blinding is that the anesthesiologist prepares the drugs and the anesthetist performs the spinal anesthesia. A student who is responsible for recording information in certain time intervals. Also, the groups are sent to the statistician using coding, and the analyst does not know about the grouping. 2-3 Postoperative nausea and vomiting. Intervention 1: Intervention group 1: Before spinal anesthesia, they will receive 5 mg of ephedrine (Sterop belgium pharmaceutical company). In order to equalize the volume of the intervention drug in all groups, after calculating the desired dose, it will be brought to 5 ml with distilled water. And it is administered intravenously. Intervention 2: Intervention group 2: Before spinal anesthesia, they will receive 100 micrograms of atropine (Caspin Pharmaceutical Company, Rasht Supply - Iran). In order to equalize the volume of the intervention drug in all groups, after calculating the desired dose, it will be brought to 5 ml with distilled water. And it is administered intravenously. Intervention 3: Intervention group 3: Before spinal anesthesia, they will receive 8 mg of ondansetron (Alborz Daru Pharmaceutical Company). In order to equalize the volume of the intervention drug in all groups, after calculating the desired dose, it will be brought to 5 ml with distilled water. And it is administered intravenously. Intervention 4: Intervention group 4: Before the spinal anesthesia, they will receive 0.3 mg per kg of ketamine (Exir pharmaceutical company - Iran). In order to equalize the volume of the intervention drug in all groups, after calculating the desired dose, it will be brought to 5 ml with distilled water. And it is administered intravenously. 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 There is no further information.
public Dr Hesamoddin Modir
Valiasr Hospital, Valiasr Square
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific Dr Hesamoddin Modir
Valiasr Hospital, Valiasr Square
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Age 18-75 years old Both genders ASA class 1 and 2 Lower limb fracture repair surgery under spinal anesthesia Consent to participate in the study 18 years 75 years Both History of drug addiction History of seasonal allergies and allergies to any of the drugs used in this study Presence of neuromuscular diseases Presence of cardiomyopathy Presence of coagulopathy Presence of an underlying disease R11 Nausea and vomiting Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Before spinal anesthesia, they will receive 5 mg of ephedrine (Sterop belgium pharmaceutical company). In order to equalize the volume of the intervention drug in all groups, after calculating the desired dose, it will be brought to 5 ml with distilled water. And it is administered intravenously. Intervention group 2: Before spinal anesthesia, they will receive 100 micrograms of atropine (Caspin Pharmaceutical Company, Rasht Supply - Iran). In order to equalize the volume of the intervention drug in all groups, after calculating the desired dose, it will be brought to 5 ml with distilled water. And it is administered intravenously. Intervention group 3: Before spinal anesthesia, they will receive 8 mg of ondansetron (Alborz Daru Pharmaceutical Company). In order to equalize the volume of the intervention drug in all groups, after calculating the desired dose, it will be brought to 5 ml with distilled water. And it is administered intravenously. Intervention group 4: Before the spinal anesthesia, they will receive 0.3 mg per kg of ketamine (Exir pharmaceutical company - Iran). In order to equalize the volume of the intervention drug in all groups, after calculating the desired dose, it will be brought to 5 ml with distilled water. And it is administered intravenously. Vomiting score according to the vomiting score table. Timepoint: In recovery, 2, 4, 6, 12 and 24 hours after the operation. Method of measurement: Physical examination. Number of times nausea occurs. Timepoint: In recovery, 2, 4, 6, 12 and 24 hours after the operation. Method of measurement: Physical examination. Severity of nausea according to visual analogue scale. Timepoint: In recovery, 2, 4, 6, 12 and 24 hours after the operation. Method of measurement: Visual Analogue Scale. The degree of sedation according to the RAMSAY SCORE. Timepoint: In recovery and 1, 2 and 4 hours after the operation. Method of measurement: RAMSAY SCORE. Dosage of Metoclopramide. Timepoint: Within 24 hours after the operation. Method of measurement: Patient file. Vice chancellor of Research of Arak University of Medical Sciences Approved 2023-06-27 Ethics Committee of Arak University of Medical Sciences Vice chancellor of Research, Prophet Azam University Complex, Arak University of Medical Sciences Arak Markazi Iran (Islamic Republic of)