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IRCT20240904062951N1 IRCT 2025-08-22 Islamic Azad University Investigating the effect of fluid infusion before spinal anesthesia on headache and low blood pressure after cesarean section Investigating the effect of intravenous fluid therapy before spinal anesthesia on theoccurrence of headache and hemodynamic disorders in caesarean section candidatesreferred to Amiralmomenin Hospital in 2023-2024 2025-07-23 anticipated 120 Complete https://irct.ir/trial/82203 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: The study is designed as single-blind. Patients will be unaware of their allocation to the intervention group (receiving intravenous fluid therapy before spinal anesthesia) or the control group. Intravenous fluids will be prepared in identical bags and coded by the anesthesia nurse. The anesthesiologist in charge and the outcome assessors (evaluating headache and hemodynamic changes after surgery) will remain blinded to the group allocation. The allocation code will be kept confidential until the end of data collection. 2-3 headache and hemodynamic disorders. Intervention 1: Intervention group: Preloading with intravenous crystalloid (e.g., Ringer’s lactate/normal saline) at [10–15 ml/kg, max 1000 ml] over [15–20 minutes], administered immediately before spinal anesthesia. Fluids are prepared in identical, coded bags. All other anesthetic management follows routine institutional protocol. Intervention 2: Control group:Patients in this group will receive 250 mL of intravenous crystalloid (Ringer’s lactate or normal saline) immediately before spinal anesthesia. The infusion will be administered over 15–20 minutes. The fluid bags will be prepared in identical, coded form to maintain blinding. All other anesthetic management will be performed according to the routine departmental protocol. No - There is not a plan to make this available Justification or reason for not sharing IPD is Patient Privacy
public Pourya cheraghi
Nastaran street
Tehran Iran (Islamic Republic of) 1811694784 +98 21 5534 6301 Ccp41510@gmail.com Islamic Azad University scientific Pourya
Nastaran street
Tehran Iran (Islamic Republic of) 1811694784 +98 21 5534 6552 Ccp41519@gmail.com Islamic Azad University Iran (Islamic Republic of) Candidates for cesarean section under spinal anesthesia Informed consent to participate in the study 16 years 50 years Female Prevention Behavior Intervention group: Preloading with intravenous crystalloid (e.g., Ringer’s lactate/normal saline) at [10–15 ml/kg, max 1000 ml] over [15–20 minutes], administered immediately before spinal anesthesia. Fluids are prepared in identical, coded bags. All other anesthetic management follows routine institutional protocol. Control group:Patients in this group will receive 250 mL of intravenous crystalloid (Ringer’s lactate or normal saline) immediately before spinal anesthesia. The infusion will be administered over 15–20 minutes. The fluid bags will be prepared in identical, coded form to maintain blinding. All other anesthetic management will be performed according to the routine departmental protocol. Incidence of post-dural puncture headache (PDPH) at 24, 48 hours, and days 3 and 7 postoperatively, assessed by patient report and pain intensity using the VAS scale (0–10). Hemodynamic disturbances, defined as systolic blood pressure decrease ≥20% from baseline, MAP <65 mmHg, or requirement for vasopressors, recorded intraoperatively. Timepoint: Hemodynamic parameters: baseline blood pressure and heart rate measured before spinal block. • Post-dural puncture headache (PDPH): assessed at 24 hours, 48 hours, and on day 3 postoperatively. Method of measurement: Hemodynamic disturbances: Blood pressure and heart rate are recorded using the operating room monitor. A decrease ≥20% from baseline or MAP <65 mmHg is considered hemodynamic disturbance. The need for vasopressors is also recorded.Post-dural puncture headache (PDPH): Assessed by patient report and pain intensity using the VAS scale (0–10). Islamic azad university Approved 2024-09-04 Ethics coomittee of islamic azad university of tehran Shariati st , attari moghadam st Tehran Tehran Iran (Islamic Republic of)