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Completed
NCT07720440
Nociception Level Index Monitoring During Cesarean Section
Conditions: Cesarean Section, Postoperative Pain After Cesarean Section, Pain Management
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Istinye University
Location: University of Health Sciences Türkiye Haseki Training and Research Hospital Istanbul Sultangazi
Summary
This prospective randomized controlled trial evaluated the effect of nociception level (NOL) index-guided intraoperative analgesia on postoperative pain management in patients undergoing elective cesarean section under general anesthesia. Sixty patients were randomly assigned to either NOL-guided analgesia or standard intraoperative monitoring. The primary outcome was postoperative pain intensity assessed using the visual analog scale (VAS) during the first 24 hours after surgery. Secondary outcomes included postoperative opioid requirements and time to first breastfeeding. The study aimed to determine whether objective intraoperative nociception monitoring could improve postoperative analgesia and enhance early maternal recovery.
Eligibility Criteria
Inclusion Criteria:
* Female patients undergoing elective cesarean section under general anesthesia.
* Ability to provide written informed consent.
Exclusion Criteria:
* Refusal to participate.
* Emergency cesarean section.
* High-risk pregnancy (including hypertensive disorders of pregnancy, diabetes mellitus, preterm labor, or fetal growth restriction).
* Placental abnormalities.
* History of allergy to any study medication.
* History of malignant hyperthermia.
* Alcohol or substance abuse.
* Severe cardiac disease or severe arrhythmia.
* Peripheral vascular disease.
* Renal or hepatic failure.
* Contraindication to corticosteroid administration.
Source: ClinicalTrials.gov (NCT07720440). StuddyBuddy aggregates publicly available trial information.