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IRCT20220614055172N1 IRCT 2022-07-03 Hamedan University of Medical Sciences The Effect of Ondansetron and Ginger on Nausea/ Vomiting, Shivering and Headache in Cesarean Section Patients Comparative Study of the Effect of Ondansetron and Ginger on Nausea/ Vomiting, Shivering and Headache after Spinal Anesthesia during and after Cesarean Section 2022-08-06 anticipated 150 Complete https://irct.ir/trial/64269 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In the random block sampling method, different modes of three groups are written on six cards and each in an envelope is placed in the package. These envelopes are placed in a box, and the researcher does not know which research units will be placed in before selecting the card. Before exposure to the research units, the midwife picking up one of the envelopes from the box without awareness of the study and groups determines which group that will be included in the study, respectively, Blinding description: In this study, participants and clinical caregivers and data analyzer will be informed of the generality and method of implementation of the study, but will not be aware of the groups and the type of intervention received That is, the participant, clinical caregiver and data analyzer will be unaware of where each participant is and what intervention has received. 3 Cesarean section. Intervention 1: First Intervention group: This group is the ginger group, which will first be prepared as Zintoma oral capsules (250 mg) produced by Gol Daroo Pharmaceutical Company. Then, 1000 mg ginger capsule will be prepared in the pharmacology laboratory of Hamadan University of Medical Sciences under the supervision of a pharmacist. After coordination with the anesthesia team and the gynecological surgery team, the patient will be given a ginger capsule (1000 mg) with 30 ml of water one hour before receiving spinal anesthesia. Intervention 2: Second Intervention group: This group is ondansetron group, which will first be prepared as ondansetron tablets (16 mg) produced by Exir Pharmaceutical Company. After coordination with the anesthesia team and the gynecological surgery team, the patient will be given an ondansetron capsule (16 mg) with 30 ml of water one hour before receiving spinal anesthesia. Intervention 3: Control group: Placebo capsule (containing rice flour) will be prepared in the pharmacology laboratory of Hamadan University of Medical Sciences under the supervision of a pharmacist. After coordination with the anesthesia team and gynecological surgery team, a placebo capsule (containing rice flour) with 30 ml of water one hour before The patient will be given spinal anesthesia. Yes - There is a plan to make this available What will be shared: All personal data is shared after unidentified individuals. Includes demographic data and data on the severity of Nausea/Vomiting, Shivering, and Headache. When: The data is shared three months after the publication of the results. To whom: All researchers can apply for the data. Conditions: The data is provided provided that they first have a clear purpose for using the data. Secondly, wherever this data is to be used, the primary data source should be mentioned. Where to obtain: Can use the the following e-mail address to receive the data. Behzadiman@yahoo.com How to obtain: After sending the request to the e-mail address, the data will be sent as soon as possible. Comments:
public Sahar Alizade
In front of Mardom's Park, Shahid Fahmideh Street, Pazhouhesh Square,
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3131 0000 arielalizade@gmail.com Hamedan University of Medical Sciences scientific Behzad Imani
In front of Mardom's Park, Shahid Fahmideh Street, Pazhouhesh Square,
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3131 0000 Behzadiman@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age range of 20 to 40 years Physical status 1 or 2 in terms of ASA criteria Complete gestational age and singleton Cesarean candidate under spinal anesthesia 20 years 40 years Female Unwilling to participate in the study History of mental disorders Body mass index greater than 35 Meniere's disease Digestive Disease Frequent Dora holes and failed spinal anesthesia Allergy to Ondansetron or Ginger Z38.01 Single liveborn infant, delivered by cesarean Prevention Prevention Placebo First Intervention group: This group is the ginger group, which will first be prepared as Zintoma oral capsules (250 mg) produced by Gol Daroo Pharmaceutical Company. Then, 1000 mg ginger capsule will be prepared in the pharmacology laboratory of Hamadan University of Medical Sciences under the supervision of a pharmacist. After coordination with the anesthesia team and the gynecological surgery team, the patient will be given a ginger capsule (1000 mg) with 30 ml of water one hour before receiving spinal anesthesia. Second Intervention group: This group is ondansetron group, which will first be prepared as ondansetron tablets (16 mg) produced by Exir Pharmaceutical Company. After coordination with the anesthesia team and the gynecological surgery team, the patient will be given an ondansetron capsule (16 mg) with 30 ml of water one hour before receiving spinal anesthesia. Control group: Placebo capsule (containing rice flour) will be prepared in the pharmacology laboratory of Hamadan University of Medical Sciences under the supervision of a pharmacist. After coordination with the anesthesia team and gynecological surgery team, a placebo capsule (containing rice flour) with 30 ml of water one hour before The patient will be given spinal anesthesia. Nausea based on visual analog scale score. Timepoint: During cesarean section (20 minutes after the start of surgery), when leaving the recovery (30 minutes after surgery is completed), 1, 2 and 4 hours after the surgery is completed. Method of measurement: Visual analog scale. Vomiting based on the vomiting frequency checklist. Timepoint: During cesarean section (20 minutes after the start of surgery), when leaving the recovery (30 minutes after surgery is completed), 1, 2 and 4 hours after the surgery is completed. Method of measurement: Vomiting frequency checklist. Shivering based on the standard shivering scale score. Timepoint: During cesarean section (20 minutes after the start of surgery), when leaving the recovery (30 minutes after surgery is completed), 1, 2 and 4 hours after the surgery is completed. Method of measurement: Standard Shivering scale based on Crossley and Mahajan criteria. Headache based on visual analog scale score. Timepoint: During cesarean section (20 minutes after the start of surgery), when leaving the recovery (30 minutes after surgery is completed), 1, 2 and 4 hours after the surgery is completed. Method of measurement: Visual analog scale. Hamedan University of Medical Sciences Approved 2022-06-25 Ethics committee of Hamadan University of Medical Sciences In front of Mardom's Park, Shahid Fahmideh Street, Pazhouhesh Square Hamadan Hamadan Iran (Islamic Republic of)