Opioid Free Anesthesia on the Quality of Early Recovery

Study Overview
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Brief Summary
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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
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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, an experienced anesthesiologist guided by ultrasound performed bilateral superficial cervical plexus block with 0.5% ropivacaine and injected 3-4ml at two points respectively; During the operation, sevoflurane (MAC1.0 - 1.4) 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； Combined with sevoflurane (MAC 0.8-1) to maintain the depth of anesthesia.

Official Title
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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

Conditions
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Opioid-free Anesthesia

Intervention / Treatment
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* Drug: T group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: C group<br>The routine anesthesia group | |
| Experimental: T group<br>Opioid-free Anesthesia | Drug: T group<br>* 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, an experienced anesthesiologist guided by ultrasound performed bilateral superficial cervical plexus block with 0.5% ropivacaine and injected 3-4ml at two points respectively; During the operation, sevoflurane (MAC1.0 - 1.4) was used to maintain the depth of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Hour 24，Hour 48，Hour 72 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Hour 24，Hour 48，Hour 72 after surgery | 
| Postoperative complication rate | Postoperative complication rate | Hour 24，Hour 48，Hour 72 after surgery | 
| Opioid consumption | morphine or equivalent daily consumption after surgery if necesssary | Hour 24，Hour 48，Hour 72 after surgery | 
| Anesthesia related adverse events | Anesthesia related adverse events | 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. | 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. | Hour 24，Hour 48，Hour 72 after surgery | 
| Incidence of chronic pain and quality of life | Incidence of chronic pain and quality of life | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroidectomy, the early quality of recovery