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IRCT20221127056627N1 IRCT 2022-12-04 Shiraz University of Medical Sciences Survey the effect of adding dexamethasone to ondansetrone or metoclopramide to increase the effect of these drugs in prevention of nausea and vomiting after caesarian section under spinal anesthesia The adjuvant effect of dexamethasone to ondansetron or metoclopramide in prevention of nausea and vomiting after spinal anesthesia for elective caesarian section 2022-11-21 anticipated 150 Complete https://irct.ir/trial/67061 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated into two groups by block randomization. In this technique, a permutation block of size 6 will be made for patients of two groups A & B. In each block, equal numbers for two groups will be considered in alternative positions. Then 25 blocks of size 6 will be selected randomly and patients will be allocated randomly and equally into three groups according to these permutation block. block sequence will be prepare by www.sealedenvelope.com, Blinding description: Antiemetic drugs are provided in the form of syringes containing 5 ml of normal saline solution by the first person, these drugs, which have the same color and size and in similar colors, are injected by the second person who is completely unaware of the contents of the syringes. The anesthesiologist, patients, and other personnel involved in the work are blinded to the drugs injected in this study. This study is double-blind. 4 esarean section. Intervention 1: Intervention group 1 or DO group: dexamethasone 8 mg (manufactured by Tehran-Shimi Company) IV plus ondansetron 4 mg (manufactured by Caspin Company ) is administered intravenously ten minutes before anesthesia. Intervention 2: Intervention group 2 or group DM: dexamethasone 8 mg((Manufactured by Tehran-Shimi Company) intravenously., and metoclopramide 10 mg (Made by Caspian Company) administered intravenously 10 minutes before anesthesia. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is against our policy
public Mojtaba Sookhakian
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 0987136474270 dr.sookhian.m@gmail.com Shiraz University of Medical Sciences scientific Zeinabsadat Fattahi
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4270 parniafattahi@rocketmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Adult women with ASA grade I or II (American Society of Anesthesiology classification) Women between 18 and 35 years old Women having elective caesarean section under spinal anesthesia 18 years 35 years Female ASA class of III or IV pregnancy induced Hypertension Patients who have received steroid medication positive history of prolonged QT interval patients who refuced to do spinal anesthesia for her O82 Encounter for cesarean delivery without indication Treatment - Drugs Treatment - Drugs Intervention group 1 or DO group: dexamethasone 8 mg (manufactured by Tehran-Shimi Company) IV plus ondansetron 4 mg (manufactured by Caspin Company ) is administered intravenously ten minutes before anesthesia. Intervention group 2 or group DM: dexamethasone 8 mg((Manufactured by Tehran-Shimi Company) intravenously., and metoclopramide 10 mg (Made by Caspian Company) administered intravenously 10 minutes before anesthesia. Nausea. Timepoint: 3 minutes and 15 minutes before the operation and 4 hours after the operation. Method of measurement: Score points based on Bellavia criteria. Vomiting. Timepoint: 3 minutes and 15 minutes before the operation and 4 hours after the operation. Method of measurement: Score points based on Bellavia criteria. Shiraz University of Medical Sciences Approved 2022-07-16 Ethics Committee of Shiraz Medical School 3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)