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临床试验/NCT05577962
NCT05577962招募中4 期

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

Beijing Friendship Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年8月1日最近更新:
适应症
干预措施
相关药物

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

No Intervention

opioid-based anesthesia

T group

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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