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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260425069157N3
Enrollment
100
Registered
2026-05-11
Start date
2026-05-22
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective Cesarean Section, Spinal Anesthesia in Cesarean Section. Encounter for cesarean delivery without indication

Interventions

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 microgra

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Gestational age of 37 to 40 weeks Singleton pregnancy ASA class I or II Informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Roghayea Neisari

Oroumia University of Medical Sciences

nisari.r@umsu.ac.ir+98 44 3346 0998

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026