drugset / Trial / NCT07864155

Opioid-Free Versus Opioid-Based Anesthesia in Thyroid Surgery

NCT07864155 ↗

Recruiting 110 enrolled Malatya Egitim Ve Arastirma Hastanesi
Non-randomizedParallel-groupOpen-labelSupportive care

Summary

This study will compare opioid-free anesthesia and opioid-based anesthesia in adult euthyroid patients undergoing elective thyroidectomy. Opioid-based anesthesia is commonly used during surgery, but opioids may be associated with adverse effects such as nausea, vomiting, respiratory depression, hyperalgesia, and increased postoperative opioid use. Opioid-free anesthesia uses non-opioid medications as part of a multimodal strategy to provide intraoperative analgesia. The main aim of this prospective randomized study is to evaluate whether opioid-free anesthesia changes the perioperative oxidative stress response compared with opioid-based anesthesia. Oxidative stress will be assessed using serum biomarkers, including native thiol, total thiol, disulfide, total antioxidant status, total oxidant status, and oxidative stress index. Eligible patients will be randomly assigned to receive either opioid-free anesthesia or fentanyl-based opioid anesthesia. Blood samples will be collected before anesthesia induction, 30 minutes after extubation, and 24 hours after surgery. The study will also compare postoperative pain scores, rescue analgesic requirement, postoperative nausea and vomiting, recovery characteristics, and intraoperative hemodynamic variables between the two anesthesia strategies.

Timeline

Start
2026-04-01
Primary completion
2027-01-31
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.4 ug/kg Intravenous
Subject Dexmedetomidine Other / unclassified 0.7 ug/kg Intravenous
Comparator Fentanyl Other / unclassified 1 ug/kg Intravenous
Comparator Fentanyl Other / unclassified 2 ug/kg Intravenous
Subject Lidocaine Other / unclassified 1 mg/kg Intravenous
Subject Lidocaine Other / unclassified 2 mg/kg Intravenous

Indications

No indication recorded.