Opioid-Free Versus Opioid-Based Anesthesia in Thyroid Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMalatya Egitim Ve Arastirma Hastanesi
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Adult patients aged 18 to 65 years
Scheduled for elective thyroidectomy
American Society of Anesthesiologists physical status I-II
Euthyroid status, defined as thyroid-stimulating hormone, free thyroxine, and free triiodothyronine levels within the reference range
Disqualifiers
Uncontrolled advanced systemic disease, including advanced cardiac, pulmonary, renal, or hepatic failure
Active infection
Use of high-dose antioxidant supplementation within the last month
Widespread inflammation related to malignancy
Trial design
Design model
Parallel
Treatments tested in this trial
Fentanyl (IV)
DrugFentanyl-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
DrugDexmedetomidine 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Opioid-Free Anesthesia GroupExperimental treatment 1 intervention
Group B: Opioid-Based Anesthesia GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Oxidative Stress Index From Preoperative Baseline to 24 Hours After Surgery
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.
Time frame
Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)Secondary outcomes
1
Change in Total Antioxidant Status (TAS)
Serum total antioxidant status (TAS) will be measured to assess systemic antioxidant capacity. The change in TAS from preoperative baseline to 24 hours after surgery will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.
Time frame
Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)2
Change in Total Oxidant Status (TOS)
Serum total oxidant status (TOS) will be measured to assess systemic oxidant burden. The change in TOS from preoperative baseline to 24 hours after surgery will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.
Time frame
Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)3
Change in Native Thiol Level
Serum native thiol levels will be measured as a component of thiol-disulfide homeostasis. The change in native thiol level from preoperative baseline to 24 hours after surgery will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.
Time frame
Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)4
Change in Total Thiol Level
Serum total thiol levels will be measured as a component of thiol-disulfide homeostasis. The change in total thiol level from preoperative baseline to 24 hours after surgery will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.
Time frame
Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)Sponsors and contacts
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Source ClinicalTrials.gov