Opioid-free AnesthesiaPhase 4opioid-freeNCT05577962
Opioid Free Anesthesia on the Quality of Early Recovery
A Phase 4 study testing OFA group (group T) in people with Opioid-free Anesthesia, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
To analyze and compare the effect of OFA scheme and traditional balanced anesthesia scheme on QoR15 after thyroidectomy, and further clarify the safety and rationality of OFA scheme in perioperative application of thyroid surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-free Anesthesia
- What is being tested?
- OFA group (group T)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Dec 2026
- Phase
- Phase 4
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Haijun Hou, +8618612568228, 77790690@qq.com
About this study
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
To analyze and compare the effect of OFA scheme and traditional balanced anesthesia scheme on QoR15 after thyroidectomy, and further clarify the safety and rationality of OFA scheme in perioperative application of thyroid surgery.
Read the detailed description
OFA scheme (group T) was given dexamethasone 8mg for anti-inflammatory and antiemetic before operation, flurbiprofen axetil 50mg for preemptive analgesia, and dexmedetomidine was infused under ECG monitoring at an initial rate of 0.5 μ G/kg (more than 10min), then changed to 0.2ug/kg/h, and stopped infusion 20 minutes before operation closure. Before induction, lidocaine (1mg/kg), esketamine (0.5mg/kg), propofol (1-2mg/kg) and rocuronium (0.6mg/kg) were infused slowly, and endotracheal intubation was carried out when the anesthetic was fully effective and the BIS value was about 40. After successful intubation.During the operation, continuous propofol (BIS-guided) plus dexmedetomidine 0.2 μg/kg/h (stopped 20 min before skin closure) plus lidocaine 1 mg/kg/h was used to maintain the depth of anesthesia; The routine anesthesia group (Group C) was induced to give sufentanil 0.3-0.5ug/kg, propofol 1-2mg/kg, rocuronium 0.6mg/kg slowly, and then intubated when the anesthetic was fully effective and the BIS value was about 40. Remifentanil was continuously pumped 0.1-0.2ug/kg during operation min. Total intravenous propofol (BIS guided) plus a continuous remifentanil infusion at 0.1-0.2 μg/kg/min was used to maintain the depth of anesthesia.
- Conditions
- Opioid-free Anesthesia
- Being tested
- OFA group (group T)
- Keywords
- thyroidectomy, the early quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFA group (group T)Drug
OFA scheme (group T) was given dexamethasone 8mg for anti-inflammatory and antiemetic before operation, flurbiprofen axetil 50mg for preemptive analgesia, and dexmedetomidine was infused under ECG monitoring at an initial rate of 0.5 μ G/kg (more than 10min), then changed to 0.2ug/kg/h, and stopped infusion 20 minutes before operation closure. Before induction, lidocaine (1mg/kg), esketamine (0.5mg/kg), propofol (1-2mg/kg) and rocuronium (0.6mg/kg) were infused slowly, and endotracheal intubation was carried out when the anesthetic was fully effective and the BIS value was about 40. After successful intubation.During the operation, continuous propofol (BIS-guided) plus dexmedetomidine 0.2 μg/kg/h (stopped 20 min before skin closure) plus lidocaine 1 mg/kg/h was used to maintain the depth of anesthesia;
| Study group | Role | What they receive |
|---|---|---|
| C group | No intervention | opioid-based anesthesia |
| T group | Experimental | Opioid-free Anesthesia Receives: Drug: OFA group (group T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The QoR-15 score
The quality of recovery-15 score,The QoR was classified as excellent (QoR-15 > 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121) or poor (QoR-15 < 90).
Measured: Hour 24 after surgery
Secondary outcomes (8)
Postoperative VAS score
Postoperative Visual Analog Scale score, For measurement of the magnitude of pain, the most used scale is "no pain" (corresponding to the scale of 0) and "pain too intense to be tolerated" (corresponding to the scale of 100)
Measured: Hour 24，Hour 48，Hour 72 after surgery
Postoperative complication rate
Postoperative complication rate
Measured: Hour 24，Hour 48，Hour 72 after surgery
Opioid consumption
morphine or equivalent daily consumption after surgery if necesssary
Measured: Hour 24，Hour 48，Hour 72 after surgery
Anesthesia related adverse events
Anesthesia related adverse events
Measured: Hour 24，Hour 48，Hour 72 after surgery
Postoperative fatigue, ICFS scores after surgery
Identity-Consequence Fatigue Scale (ICFS) in patients was used to assess the intensity of fatigue.A questionnaire was developed using the 48 items that remained following the content analysis. All items were rated on six-point adjectival scales with anchors from "not at all" to "all of the time" or "not at all" to "more often than usual."
Measured: Hour 24，Hour 48，Hour 72 after surgery
Postoperative mental state
Postoperative Mini-Mental State Examination (MMSE) scores.MMSE <27 was taken to indicate cognitive impairment.
Measured: Hour 24，Hour 48，Hour 72 after surgery
Incidence of chronic pain and quality of life
Incidence of chronic pain and quality of life
Measured: 3 months after surgery
the QoR-15 score 48,72 hours after surgery
the QoR-15 score 48,72 hours after surgery
Measured: 48,72 hours after sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Aug 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-free AnesthesiaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haijun Hou, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577962
- Sponsor's protocol ID
- opioid-free anesthesia
- Acronym
- opioid-free
- Status last verified
- Jun 2026
- First submitted
- 7 Oct 2022
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No