Opioid-Free Versus Opioid-Based Anesthesia in Thyroid Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Fentanyl (IV): Fentanyl-based intraoperative analgesia consisting of fentanyl 1-2 mcg/kg intravenously at induction followed by fentanyl infusion at 1-2 mcg/kg/hour during surgery. No additional fentanyl bolus will be administered, and the total intraoperative fentanyl dose will not exceed 5 mcg/kg.

Dexmedetomidine and lidocaine: Dexmedetomidine will be administered intravenously at 0.4-0.7 mcg/kg/hour without a loading dose. The infusion will be discontinued 10-15 minutes before the end of surgery. Intravenous lidocaine will be administered as a 1-1.5 mg/kg bolus followed by a continuous infusion of 1-2 mg/kg/hour during surgery. The lidocaine infusion will be discontinued at the end of surgery.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Oxidative Stress Index From Preoperative Baseline to 24 Hours After Surgery — Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)
  Oxidative Stress Index (OSI) will be calculated from serum total oxidant status (TOS) and total antioxidant status (TAS). The primary outcome will be the change in OSI from the preoperative baseline measurement to the measurement obtained 24 hours after surgery. The change in OSI will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.

Trial sites (1)

Other trials for the same condition