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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The QoR-15 score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
C group
opioid-based anesthesia
T group
Opioid-free Anesthesia
干预措施: OFA group (group T) (Drug)
结局指标
主要结局
The QoR-15 score
时间窗: 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).
次要结局
- the QoR-15 score 48,72 hours after surgery(48,72 hours after sugery)
- Incidence of chronic pain and quality of life(3 months after surgery)
- Postoperative VAS score(Hour 24,Hour 48,Hour 72 after surgery)
- Postoperative fatigue, ICFS scores after surgery(Hour 24,Hour 48,Hour 72 after surgery)
- Opioid consumption(Hour 24,Hour 48,Hour 72 after surgery)
- Anesthesia related adverse events(Hour 24,Hour 48,Hour 72 after surgery)
- Postoperative complication rate(Hour 24,Hour 48,Hour 72 after surgery)
- Postoperative mental state(Hour 24,Hour 48,Hour 72 after surgery)
