ThyroidectomyOFA-OBANCT07864155
Opioid-Free Versus Opioid-Based Anesthesia in Thyroid Surgery
A study testing Fentanyl (IV) and Dexmedetomidine and lidocaine in people with Thyroidectomy and Oxidative Stress, run by Malatya Egitim Ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroidectomy, Oxidative Stress, Anesthesia
- What is being tested?
- Fentanyl (IV) and Dexmedetomidine and lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Able to understand the study procedures and provide written informed consent
Who cannot join
- 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
- Known severe allergy or contraindication to any study medication
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Malatya Turgut Ozal University Faculty of Medicine, Malatya Training and Research Hospital
Malatya, 44000
Leman Acun Delen, Associate Professor, +904222118019 ext. 2035, leman.delen@ozal.edu.tr
Leman Acun Delen, Associate Professor
About this study
Official title: Effects of Opioid-Free and Opioid-Based Anesthesia on Perioperative Oxidative Stress Biomarkers in Euthyroid Adult Patients Undergoing Elective Thyroidectomy: A Prospective Clinical 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.
Read the detailed description
This is a single-center, prospective, randomized, parallel-group clinical study. Adult euthyroid patients scheduled for elective thyroidectomy will be randomized in a 1:1 ratio to opioid-free anesthesia or opioid-based anesthesia. The opioid-based group will receive fentanyl-based intraoperative analgesia. The opioid-free group will receive multimodal non-opioid analgesia with dexmedetomidine and lidocaine. General anesthesia will otherwise be standardized, including propofol-based total intravenous anesthesia, neuromuscular blockade, antiemetic prophylaxis, and postoperative non-opioid analgesia.
The primary focus of the study is the perioperative oxidative stress response. Venous blood samples will be collected at three time points: before anesthesia induction, 30±10 minutes after extubation in the post-anesthesia care unit, and 24±2 hours after surgery. Serum native thiol, total thiol, disulfide, total antioxidant status, and total oxidant status will be measured, and oxidative stress index will be calculated from total oxidant status and total antioxidant status.
Secondary clinical outcomes will include postoperative pain intensity, rescue opioid consumption, postoperative nausea and vomiting, recovery characteristics, and intraoperative hemodynamic stability.
- Conditions
- Thyroidectomy, Oxidative Stress, Anesthesia
- Being tested
- Fentanyl (IV), Dexmedetomidine and lidocaine
- Keywords
- Opioid-free anesthesia, Opioid-based anesthesia, Thyroid surgery, Total antioxidant status, Thiol-disulfide homeostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl (IV)Drug
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 lidocaineDrug
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 group | Role | What they receive |
|---|---|---|
| Opioid-Free Anesthesia Group | Experimental | Participants in this group will undergo elective thyroidectomy under standardized propofol-based total intravenous general anesthesia with multimodal opioid-free intraoperative analgesia. Analgesia will be provided with dexmedetomidine infusion and intravenous lidocaine bolus followed by infusion. No intraoperative opioid will be administered as part of the planned anesthesia protocol. Receives: Drug: Dexmedetomidine and lidocaine |
| Opioid-Based Anesthesia Group | Active comparator | Participants in this group will undergo elective thyroidectomy under standardized propofol-based total intravenous general anesthesia with fentanyl-based intraoperative analgesia. Fentanyl will be administered at induction and continued as an intravenous infusion during surgery according to the study protocol. Receives: Drug: Fentanyl (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)
Secondary outcomes (9)
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.
Measured: Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)
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.
Measured: Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)
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.
Measured: Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)
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.
Measured: Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)
Change in Disulfide Level
Serum disulfide levels will be calculated as a component of thiol-disulfide homeostasis. The change in disulfide level from preoperative baseline to 24 hours after surgery will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.
Measured: Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)
Postoperative Pain Intensity Assessed Using the Visual Analog Scale (VAS)
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.
Measured: During the first 24 hours after surgery
Total Rescue Opioid Consumption Within 24 Hours After Surgery
Total rescue opioid consumption during the first 24 hours after surgery will be recorded for each participant and compared between the opioid-free anesthesia and opioid-based anesthesia groups.
Measured: From the end of surgery to 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting (PONV)
The occurrence of postoperative nausea and/or vomiting (PONV) during the first 24 hours after surgery will be recorded for each participant. The incidence of PONV will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.
Measured: From the end of surgery to 24 hours after surgery
Intraoperative Hemodynamic Parameters
Intraoperative hemodynamic parameters will be assessed using mean arterial pressure (MAP, mmHg) and heart rate (beats per minute), recorded at predefined time points during anesthesia. Changes in these parameters over the intraoperative period will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.
Measured: From induction of anesthesia to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Apr 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be prospectively enrolled into one of two groups according to the anesthesia strategy selected by the attending anesthesiologist based on routine clinical assessment and patient characteristics. No random allocation will be performed. Both groups will undergo elective thyroidectomy under standardized propofol-based total intravenous general anesthesia. The opioid-free anesthesia group will receive multimodal non-opioid intraoperative analgesia with dexmedetomidine and intravenous lidocaine, while the opioid-based anesthesia group will receive fentanyl-based intraoperative analgesia.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malatya Egitim Ve Arastirma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Leman Acun Delen, Malatya Egitim Ve Arastirma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864155
- Sponsor's protocol ID
- OFA-OBA-THYR-01
- Other IDs
- 2026/45
- Acronym
- OFA-OBA
- Status last verified
- Oct 2026
- First submitted
- 29 May 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Opioid-Free and Opioid-Based Anesthesia on Perioperative Oxidative Stress Biomarkers in Euthyroid Adult Patients Undergoing Elective Thyroidectomy: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07864155
- Acronym / sponsor ID
- OFA-OBA / OFA-OBA-THYR-01
- Conditions
- Thyroidectomy, Oxidative Stress, Anesthesia
- Keywords
- Opioid-free anesthesia, Opioid-based anesthesia, Thyroid surgery, Total antioxidant status, Thiol-disulfide homeostasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Malatya Egitim Ve Arastirma HastanesiOther government
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, prospective, randomized, parallel-group clinical study. Adult euthyroid patients scheduled for elective thyroidectomy will be randomized in a 1:1 ratio to opioid-free anesthesia or opioid-based anesthesia. The opioid-based group will receive fentanyl-based intraoperative analgesia. The opioid-free group will receive multimodal non-opioid analgesia with dexmedetomidine and lidocaine. General anesthesia will otherwise be standardized, including propofol-based total intravenous anesthesia, neuromuscular blockade, antiemetic prophylaxis, and postoperative non-opioid analgesia.
The primary focus of the study is the perioperative oxidative stress response. Venous blood samples will be collected at three time points: before anesthesia induction, 30±10 minutes after extubation in the post-anesthesia care unit, and 24±2 hours after surgery. Serum native thiol, total thiol, disulfide, total antioxidant status, and total oxidant status will be measured, and oxidative stress index will be calculated from total oxidant status and total antioxidant status.
Secondary clinical outcomes will include postoperative pain intensity, rescue opioid consumption, postoperative nausea and vomiting, recovery characteristics, and intraoperative hemodynamic stability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be prospectively enrolled into one of two groups according to the anesthesia strategy selected by the attending anesthesiologist based on routine clinical assessment and patient characteristics. No random allocation will be performed. Both groups will undergo elective thyroidectomy under standardized propofol-based total intravenous general anesthesia. The opioid-free anesthesia group will receive multimodal non-opioid intraoperative analgesia with dexmedetomidine and intravenous lidocaine, while the opioid-based anesthesia group will receive fentanyl-based intraoperative analgesia.
| Arm | Type | Receives |
|---|---|---|
| Opioid-Free Anesthesia Group | Experimental | Drug: Dexmedetomidine and lidocaineParticipants in this group will undergo elective thyroidectomy under standardized propofol-based total intravenous general anesthesia with multimodal opioid-free intraoperative analgesia. Analgesia will be provided with dexmedetomidine infusion and intravenous lidocaine bolus followed by infusion. No intraoperative opioid will be administered as part of the planned anesthesia protocol. |
| Opioid-Based Anesthesia Group | Active comparator | Drug: Fentanyl (IV)Participants in this group will undergo elective thyroidectomy under standardized propofol-based total intravenous general anesthesia with fentanyl-based intraoperative analgesia. Fentanyl will be administered at induction and continued as an intravenous infusion during surgery according to the study protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Able to understand the study procedures and provide written informed consent
Key exclusion criteria (6 listed)
- 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
- Known severe allergy or contraindication to any study medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Opioid-Based Anesthesia Group |
| Dexmedetomidine and lidocaineDexmedetomidine 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. | Drug | Opioid-Free Anesthesia Group |
Primary outcome
Change in Oxidative Stress Index From Preoperative Baseline to 24 Hours After Surgery
Time frame: 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.
9 secondary outcomes
Change in Total Antioxidant Status (TAS)
Time frame: Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)
Change in Total Oxidant Status (TOS)
Time frame: Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)
Change in Native Thiol Level
Time frame: Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)
Change in Total Thiol Level
Time frame: Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)
Change in Disulfide Level
Time frame: Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)
Postoperative Pain Intensity Assessed Using the Visual Analog Scale (VAS)
Time frame: During the first 24 hours after surgery
Total Rescue Opioid Consumption Within 24 Hours After Surgery
Time frame: From the end of surgery to 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: From the end of surgery to 24 hours after surgery
Intraoperative Hemodynamic Parameters
Time frame: From induction of anesthesia to the end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl (IV) and Dexmedetomidine and lidocaine in people with Thyroidectomy and Oxidative Stress, run by Malatya Egitim Ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leman Acun Delen, Associate Professor (+904222118019 ext. 2035, leman.delen@ozal.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxidative Stress Index From Preoperative Baseline to 24 Hours After Surgery (time frame: Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.