Opioid-Free Anesthesia to Improve Early Recovery After Thyroid Surgery
Official title: The Effect of Opioid-free Anesthesia Protocol on the Early Quality of Recovery After Thyroidectomy (TOFA Trial): Study Protocol for a Prospective, Monocentric, Randomized, Single-blinded Trial
Run by Beijing Friendship Hospital · NCT05577962 · Data updated 2026-11-12
This study tests an opioid-free anesthesia plan against a traditional approach to see if it improves early recovery after thyroidectomy for adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | October 1, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT05577962 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) undergoing elective thyroidectomy under general anesthesia, ASA I–II, who sign informed consent and have no chronic opioid/NSAID use or major contraindications.
✕Probably not a fit
Patients with long-term opioid or NSAID use, significant comorbidities, or contraindications to study drugs may not benefit and could be at risk.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, interventional trial compares an opioid-free anesthesia (OFA) scheme with a conventional balanced anesthesia during elective thyroidectomy. The OFA protocol uses dexamethasone, flurbiprofen, dexmedetomidine, lidocaine, esketamine, and propofol with BIS guidance to maintain anesthesia, aiming to reduce opioid exposure. Primary outcome centers on QoR-15 scores in the early postoperative period, with safety and rationality of OFA monitored closely. Eligible participants are adults (18+) with ASA I–II undergoing elective thyroidectomy, without chronic opioid or NSAID use and without major comorbidities. The study is conducted at Beijing Friendship Hospital, Capital Medical University.
Why it matters
Potential benefit: If successful, patients may experience better early recovery and fewer opioid-related side effects after thyroid surgery.
How similar studies have gone: Previous work in perioperative care suggests opioid-sparing strategies can be feasible and may improve recovery, but evidence specific to OFA in thyroidectomy is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Patients undergoing elective thyroidectomy under general anesthesia * \>18 year old * The informed consent form has been signed * American Society of Anesthesiologists (ASA) anesthesia grade I - II Exclusion Criteria: * Long term use of opioids * Long term use of NSAIDs * Have a history of psychosis, epilepsy, preoperative anxiety, depression, and emotional management disorders * Patients with increased gastric contents reflux and respiratory tract aspiration * Operation time\>3h * Severe liver and kidney insufficiency, cardiac insufficiency, bradycardia with 2 ° II or 3° atrioventricular block * Those who are allergic to or have contraindications to drugs that may be used in the test * Those who cannot cooperate with researchers
Where it's running
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Haijun Hou — Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Study coordinator: Haijun Hou
- Email: lumen208@foxmail.com
- Phone: +8618612568228
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.