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IRCT20260907070952N1 IRCT 2026-09-14 Shahre-kord University of Medical Sciences Comparison of the Effects of Dexamethasone and Ondansetron on Preventing Headache After Spinal Anesthesia in Women Undergoing Cesarean Section comparison of The effectiveness of intravenous dexamethasone with intravenous ondansetron in preventingheadache after spinal anesthesia in cesarean scetion 2026-09-23 anticipated 120 Recruiting https://irct.ir/trial/93135 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: This study is a double-blind randomized clinical trial in which neither the patients nor the researcher is aware of the medication administered. Eligible patients will be selected using convenience sampling. After obtaining informed consent, the participants will be randomly allocated using Random Allocation Software into three groups of 40 patients each: Group A (dexamethasone), Group B (ondansetron), and the control group (distilled water), Blinding description: This study will be conducted using a double-blind design, such that neither the patients nor the researcher/outcome assessor will be aware of the treatment allocation. The study medications, including dexamethasone, ondansetron, and distilled water, will be prepared in equal final volumes and placed in identical coded syringes by an independent individual who is not involved in the assessment or data collection. The coded syringes will then be provided to the study investigator, and the treatment allocation codes will remain concealed until completion of data collection and analysis. In case of a medical emergency requiring knowledge of the administered treatment, the blinding code may be broken for the respective patien. 1-2 Prevention of Post-Dural Puncture Headache Following Spinal Anesthesia. Intervention 1: Intervention group: Dexamethasone at a dose of 4 mg is diluted with distilled water to a total volume of 4 mL and administered intravenously immediately after delivery and umbilical cord clamping. Intervention 2: Intervention group: Ondansetron at a dose of 8 mg is diluted to a total volume of 4 mL and administered intravenously immediately after delivery and umbilical cord clamping. Intervention 3: Control group: They receive 4 mL of distilled water, which is administered intravenously immediately after delivery and umbilical cord clamping. 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 I don't have any plans to publish the data for now.
public Maryam Sadeghi
No. 2, 41, Mellat Ave, Shahrekord
Shahrekord Iran (Islamic Republic of) 0 +98 38 3222 0727 sadeghi150@yahoo.com Shahre-kord University of Medical Sciences scientific Maryam Sadeghi
No. 2, 41, Mellat Ave, Shahrekord
Shahrekord Iran (Islamic Republic of) 0 +98 38 3222 0727 sadeghi150@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) The patient's willingness to participate in the study and completion of the informed consent form. Patients who are candidates for elective cesarean section under spinal anesthesia Patients aged 18–50 years Absence of concurrent infectious disease Absence of moderate-to-severe chronic headache within 24 hours before anesthesia. No administration of analgesics or medications with analgesic properties within 24 hours before anesthesia. Absence of substance abuse. Absence of preeclampsia or gestational diabetes mellitus. No known history of drug hypersensitivity to dexamethasone or ondansetron. American Society of Anesthesiologists (ASA) physical status classification I–II No use of systemic corticosteroids during the preceding two weeks. No known coagulation disorders (platelet count <100,000/µL, INR ≥1.6, or prolonged PT). No use of anticoagulant medications such as low-molecular-weight heparin (LMWH) within 12 hours before spinal anesthesia, or other antiplatelet medications. Absence of spinal abnormalities (such as severe scoliosis or lumbar tumors) that may interfere with spinal anesthesia Adequate cooperation to complete the questionnaires and assess pain intensity using the Visual Analog Scale (VAS Normal electrocardiogram (ECG) 18 years 50 years Female Any change in the anesthesia technique Occurrence of surgical or anesthetic complications Prolongation of the surgical procedure to more than 3 hours The patient's desire to withdraw from the study A history of diabetes mellitus Prevention Prevention Prevention Intervention group: Dexamethasone at a dose of 4 mg is diluted with distilled water to a total volume of 4 mL and administered intravenously immediately after delivery and umbilical cord clamping. Intervention group: Ondansetron at a dose of 8 mg is diluted to a total volume of 4 mL and administered intravenously immediately after delivery and umbilical cord clamping. Control group: They receive 4 mL of distilled water, which is administered intravenously immediately after delivery and umbilical cord clamping. Post-Dural Puncture Headache Following Spinal Anesthesia. Timepoint: 6, 12, 24, 48, and 72 hours after spinal anesthesia. Method of measurement: Visual Analogue Scale. Shahre-kord University of Medical Sciences Approved 2026-08-31 Ethics Committee of Shahrekord University of Medical Sciences رحمتیه دانشگاه علوم پزشکی شهرکرد دانشکده پزشکی شهرکرد Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)