Opioid-free Anesthesia
Conditions
Keywords
thyroidectomy, the early quality of recovery
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.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
DRUGOFA 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 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;
Sponsors
Beijing Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The QoR-15 score | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative VAS score | 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) |
| Postoperative complication rate | Hour 24，Hour 48，Hour 72 after surgery | Postoperative complication rate |
| Opioid consumption | Hour 24，Hour 48，Hour 72 after surgery | morphine or equivalent daily consumption after surgery if necesssary |
| Anesthesia related adverse events | Hour 24，Hour 48，Hour 72 after surgery | Anesthesia related adverse events |
| Postoperative fatigue, ICFS scores after surgery | 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." |
| Postoperative mental state | Hour 24，Hour 48，Hour 72 after surgery | Postoperative Mini-Mental State Examination (MMSE) scores.MMSE \<27 was taken to indicate cognitive impairment. |
| Incidence of chronic pain and quality of life | 3 months after surgery | Incidence of chronic pain and quality of life |
| the QoR-15 score 48,72 hours after surgery | 48,72 hours after sugery | the QoR-15 score 48,72 hours after surgery |
Countries
China
Contacts
CONTACTHaijun Hou
CONTACTlu liu
PRINCIPAL_INVESTIGATORHaijun Hou
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Outcome results
None listed