Clinical trial NCT05577962: Opioid Free Anesthesia on the Quality of Early Recovery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid-free Anesthesia
Keywords: thyroidectomy
the early quality of recovery
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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, 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.

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

Primary outcomes:
measure: The QoR-15 score
timeFrame: Hour 24，Hour 48，Hour 72 after surgery
Secondary outcomes:
measure: Postoperative VAS score
timeFrame: Hour 24，Hour 48，Hour 72 after surgery
measure: Postoperative complication rate
timeFrame: Hour 24，Hour 48，Hour 72 after surgery
measure: Opioid consumption
timeFrame: Hour 24，Hour 48，Hour 72 after surgery
measure: Anesthesia related adverse events
timeFrame: Hour 24，Hour 48，Hour 72 after surgery
measure: Postoperative fatigue, ICFS scores after surgery
timeFrame: Hour 24，Hour 48，Hour 72 after surgery
measure: Postoperative mental state
timeFrame: Hour 24，Hour 48，Hour 72 after surgery
measure: Incidence of chronic pain and quality of life
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Haijun Hou
Study officials:
affiliation: Beijing Friendship Hospital
name: Haijun Hou
role: PRINCIPAL_INVESTIGATOR
References: