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IRCT20251010067579N1 IRCT 2025-12-09 Oroumia University of Medical Sciences comparison of sedative dosage of Propofol and Dexamethasone on post-dural puncture headache in women undergoing elective caesarean section comparison of sedative dosage of Propofol and Dexamethasone on post-dural puncture headache after spinal anesthesia in women candidates for elective caesarean section 2025-12-22 anticipated 150 Complete https://irct.ir/trial/87819 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Use of Random allocation software, Blinding description: ​This study will be conducted as a double-blind randomized clinical trial. This means that the participants (pregnant women undergoing elective Cesarean section) and the study investigator/outcome assessor (who collects the outcome data) will be kept unaware of the type of drug administered to the patient. ​To ensure blinding, the study drugs (Propofol and Dexamethasone) will be prepared by an anesthesiologist who is not involved in the patient's anesthesia or post-operative management. The drugs will be prepared in identical volume coded syringes. These syringes will be coded so that neither the patient nor the investigator collecting the data (e.g., headache score via VAS) will be able to identify which treatment group (Group D or Group P) the patient belongs to. Furthermore, the data analyst may also remain blinded until the final data analysis is complete to prevent bias in result interpretation. 3 post-dural puncture headache after spinal anesthesia. Intervention 1: Intervention group: Propofol. Intervention 2: Intervention group: Dexamethasone. Yes - There is a plan to make this available What will be shared: De-identified Individual Participant Data (IPD) including demographic variables, headache intensity scores based on VAS criteria, and hemodynamic parameters (SBP, DBP, MAP, HR, SPO2) along with the study protocol will be available for sharing. When: Access to data will be available 6 months after the publication of the final results and will continue for 2 years. To whom: Researchers employed in academic and scientific institutions who intend to conduct meta-analysis or systematic reviews on clinical trial data in the field of anesthesia management and postoperative pain. Conditions: Data is usable solely for secondary statistical analysis and inclusion in meta-analysis studies. Use of data is conditional upon citing the original source and adhering to publication ethics. Where to obtain: Dr. Nasim Shamsa (Assistant Professor of Anesthesiology, Urmia University of Medical Sciences). Aiden Kharazi Email: aiden.kharazi@gmail.com How to obtain: Applicants must send their written request, including the research proposal and analysis objectives, to the corresponding author's email address. Upon scientific and ethical review by the principal investigators, data will be shared as an encrypted file. Comments:
public Aiden Kharazi
4th floor, Taban tower, Homafar St, valiasr
Tabriz Iran (Islamic Republic of) 5157653935 +98 41 3329 1466 aiden.kharazi@gmail.com Oroumia University of Medical Sciences scientific Aiden Kharazi
4th floor, Taban tower, Homafar St, valiasr
Tabriz Iran (Islamic Republic of) 5157653935 +98 41 3329 1466 aiden.kharazi@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) American Society of Anesthesiologists Physical status Classification I or II (ASA I or II status). Candidates for elective cesarean section surgery. Pregnant women between 18 to 45 years of age. Provision of written informed consent to participate in the study. Absence of absolute contraindication to spinal anesthesia. 18 years 45 years Female High-risk or induced pregnancy Obesity (Body Mass Index or BMI greater than 38kg/m2) Presence of Thyroid disorders Presence of Type I or II Diabetes mellitus History of drug abuse or corticosteroid use Presence of Chronic or uncontrolled medical conditions Hypertension and Cardiovascular disease Fever exceeding 38 degrees Celsius History of Chronis headaches (e.g., Migraine) Absolute contraindication of spinal anesthesia Need for any change in anesthesia technique Occurrence of hemorrhage requiring blood transfusion Allergy to the study medications (Propofol or Dexamethasone) O89.4 Spinal and epidural anesthesia-induced headache during the puerperium Treatment - Drugs Treatment - Drugs Intervention group: Propofol Intervention group: Dexamethasone Headache score. Timepoint: 1, 2, 24 hours and 2nd to 7th days after surgery. Method of measurement: Visual analog scale. Systolic Blood Pressure. Timepoint: 1, 2, 24 hours after surgery. Method of measurement: Millimeter of mercury (sphygmomanometer). Diastolic Blood Pressure. Timepoint: 1, 2, 24 hours after surgery. Method of measurement: Millimeter of mercury (sphygmomanometer). Mean Arterial Pressure. Timepoint: 1, 2, 24 hours after surgery. Method of measurement: Millimeter of mercury (calculated via specific formula). Heart rate. Timepoint: 1, 2, 24 hours after surgery. Method of measurement: Beats per minute (Pulse oximetry). Peripheral Oxygen Saturation. Timepoint: 1, 2, 24 hours after surgery. Method of measurement: Percentage (Pulse oximetry). Oroumia University of Medical Sciences Approved 2025-07-30 Research Ethics Committee of Imam Khomeini Educational and Medical Center, Urmia University of Medic Emam Khomeini University Hospital, Ershad Ave, Modarres Blvd, Urmia Urmia West Azarbaijan Iran (Islamic Republic of)