Menu
Recruiting NCT05577962

Opioid Free Anesthesia on the Quality of Early Recovery

Phase IV Interventional Opioid-free Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OFA group (group T).
Who it may be relevant to
Registry conditions: Opioid-free Anesthesia. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Interventions

  • Drug OFA group (group T)
    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 intubatio

Primary outcome measures

  • The QoR-15 score [Time frame: Hour 24 after surgery]
Secondary outcome measures (8)
  • Postoperative VAS score [Time frame: Hour 24，Hour 48，Hour 72 after surgery]
  • Postoperative complication rate [Time frame: Hour 24，Hour 48，Hour 72 after surgery]
  • Opioid consumption [Time frame: Hour 24，Hour 48，Hour 72 after surgery]
  • Anesthesia related adverse events [Time frame: Hour 24，Hour 48，Hour 72 after surgery]
  • Postoperative fatigue, ICFS scores after surgery [Time frame: Hour 24，Hour 48，Hour 72 after surgery]
  • Postoperative mental state [Time frame: Hour 24，Hour 48，Hour 72 after surgery]
  • Incidence of chronic pain and quality of life [Time frame: 3 months after surgery]
  • the QoR-15 score 48,72 hours after surgery [Time frame: 48,72 hours after sugery]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Beijing Friendship Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT05577962 · opioid-free anesthesia

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗