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IRCT20260425069157N3 IRCT 2026-05-11 Oroumia University of Medical Sciences Evaluation of the Effect of Adding Fentanyl to Cesarean Section Anesthesia on Maternal and Neonatal Outcomes Studying the effects of intrathecal fentanyl on maternal hemodynamic changes and neonatal Apgar in elective cesarean sections 2026-05-22 anticipated 100 Recruiting https://irct.ir/trial/89653 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: One hundred patients who are candidates for elective cesarean section will be randomly allocated into intervention and control groups using block randomization based on computer‑generated numbers created by Random Allocation software. Patients in the intervention group (intrathecal fentanyl group) will receive a solution containing 0.5% hyperbaric bupivacaine (10–12 mg) plus 25 µg fentanyl (0.5 mL). Patients in the control group will receive only a solution containing 0.5% hyperbaric bupivacaine (10–12 mg), Blinding description: The study will be conducted in a double‑blind manner; therefore, the medications will be prepared and administered by an anesthesiologist who is not involved in outcome assessment. Consequently, both the patients and the outcome assessor will be blinded to the group allocation (intervention or control). 3 Elective Cesarean Section, Spinal Anesthesia in Cesarean Section. Intervention 1: Intervention group: Patients in the intervention group (intrathecal fentanyl group) will receive a solution containing 10–12 mg of 0.5% hyperbaric bupivacaine combined with 25 micrograms of fentanyl (0.5 mL). Intervention 2: Control group: Patients in the control group will receive only a solution containing 10–12 mg of 0.5% hyperbaric bupivacaine. 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 will make a decision to publish after the completion of the project and according to the results
public Dr. Roghayea Neisari
Kosar Comprehensive Women’s Educational and Medical Center., Hasani Street., Urmia
Urmia Iran (Islamic Republic of) 5718748983 +98 44 3346 0998 nisari.r@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Roghayea Neisari
Kosar Comprehensive Women’s Educational and Medical Center., Hasani Street., Urmia
Urmia Iran (Islamic Republic of) 5715859497 +98 44 3346 0998 nisari.r@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Gestational age of 37 to 40 weeks Singleton pregnancy ASA class I or II Informed consent to participate in the study no limit no limit Female Presence of maternal diseases such as preeclampsia Severe cardiovascular diseases Hepatic or renal diseases Known hypersensitivity to fentanyl or local anesthetic drugs Presence of contraindications to spinal anesthesia (such as coagulation disorders or infection at the injection site) Emergency delivery or fetal distress Morbid obesity (BMI > 40) and cases with severe bleeding O82 Encounter for cesarean delivery without indication Treatment - Drugs Treatment - Drugs Intervention group: Patients in the intervention group (intrathecal fentanyl group) will receive a solution containing 10–12 mg of 0.5% hyperbaric bupivacaine combined with 25 micrograms of fentanyl (0.5 mL). Control group: Patients in the control group will receive only a solution containing 10–12 mg of 0.5% hyperbaric bupivacaine Maternal hemodynamic changes, including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR). Timepoint: Before spinal anesthesia (baseline) and at 1, 3, 5, 10, and 15 minutes after spinal anesthesia. Method of measurement: Hemodynamic parameters are measured and recorded using standard anesthesia monitoring equipment, including a non‑invasive blood pressure monitor and ECG. Neonatal Apgar score at 1 and 5 minutes after birth. Timepoint: At 1 minute and 5 minutes after birth. Method of measurement: Apgar score is assessed by the neonatal team based on the five standard components: heart rate, respiratory effort, muscle tone, reflex irritability, and skin color. Oroumia University of Medical Sciences Approved 2026-01-23 Ethics Committee of Imam Khomeini Hospital Imam Khomeini University Hospital., Ershad Ave., Modarres Blvd., Urmia., Iran Urmia West Azarbaijan Iran (Islamic Republic of)