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NCT Number: NCT05577962

Opioid Free Anesthesia on the Quality of Early Recovery

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

Haijun Hou

CONTACT

[email protected]

+8618612568228

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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;

Primary outcomes

  1. The QoR-15 score

    Time frame: Hour 24 after surgery

    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).

Secondary outcomes

  1. Postoperative VAS score

    Time frame: Hour 24,Hour 48,Hour 72 after surgery

    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)

  2. Postoperative complication rate

    Time frame: Hour 24,Hour 48,Hour 72 after surgery

    Postoperative complication rate

  3. Opioid consumption

    Time frame: Hour 24,Hour 48,Hour 72 after surgery

    morphine or equivalent daily consumption after surgery if necesssary

  4. Anesthesia related adverse events

    Time frame: Hour 24,Hour 48,Hour 72 after surgery

    Anesthesia related adverse events

  5. Postoperative fatigue, ICFS scores after surgery

    Time frame: Hour 24,Hour 48,Hour 72 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."

  6. Postoperative mental state

    Time frame: Hour 24,Hour 48,Hour 72 after surgery

    Postoperative Mini-Mental State Examination (MMSE) scores.MMSE <27 was taken to indicate cognitive impairment.

  7. Incidence of chronic pain and quality of life

    Time frame: 3 months after surgery

    Incidence of chronic pain and quality of life

  8. the QoR-15 score 48,72 hours after surgery

    Time frame: 48,72 hours after sugery

    the QoR-15 score 48,72 hours after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study 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

Acronym: opioid-free

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 13, 2022
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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