跳至主要内容
临床试验/NCT05427825
NCT05427825Unknown不适用

Anesthetic Protocols for Enhance Recovery After Metastatic Spine Tumor Resection Surgery: a Randomized Controlled Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Postoperative quality of recovery-15 score (QoR-15)

研究概览

简要总结

Spinal metastases account for 60% of all malignant bone metastases and represent a medically important treatment goal. For patients with malignant tumors diagnosed at this stage, performing En bloc spondylectomy with wide margin of resection facilitate the improvement in quality of life including ambulatory ability, daily activities independence and attenuation of bone pain. However, En bloc spondylectomy is a major operation with long operation time and frequent hemodynamic instability during the operation. Therefore, the anesthetic care plays an important role and an enhanced recovery after surgery (ERAS) is the goal.

For the ERAS anesthesia protocol for En bloc spondylectomy, we propose two major components to achieve this goal: (1) an encephalographic spectrum guided multimodal anesthesia combined with ultrasound-guided nerve block and (2) the advanced machine-learning algorithm index, namely the hypotension predictive index (HPI) guided hemodynamic protocol.

详细描述

The anesthetic protocol comprises of two major proposed components to enhanced recovery after spine cancer total en bloc resection. First, a multimodal general anesthesia consisting of GABAnergic hypnotic agent (propofol or sevoflurane), ketamine and dexmedetomidine was conducted by using the encephalographic density spectrum array. In addition, ultrasound-guided erector spinae plane block is applied. These techniques potentially prevent anesthesia induced delirium and may profoundly improve postoperative analgesic quality. Second, advanced hemodynamic monitoring device, namely the hypotensio predictive index, will be used for prevention of intraoperative hypotension and facilitate precise transfusion protocol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing metastatic spine cancer resection surgery

排除标准

  • Expected survival less than 6 months
  • Previous surgery or radiotherapy for the spine metastasis

结局指标

主要结局

Postoperative quality of recovery-15 score (QoR-15)

时间窗: 3 days

Comparing the quality of recovery-15 score (0-150) at the first and third postoperative days

次要结局

  • Delirium incidence(3 days)
  • Pain intensity(3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验