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临床试验/NCT05663242
NCT05663242招募中4 期

To Compare the Effects of Intraoperative Use of Intravenous Anesthetics Propofol and Inhaled Anesthetics Sevoflurane on the Prognosis of Patients Undergoing Surgery for Primary Lung Tumors and the Investigation of Its Mechanism of Action.

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年12月27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
300
试验地点
1
主要终点
Overall survival

研究概览

简要总结

This is a two-arm, parallel-group randomized clinical trial. Routine perioperative care would be performed in volunteers with primary early lung cancer. The study will enroll approximately 300 volunteers to compare the progression-free or overall survival in patients undergoing video-assisted thoracoscopic surgery (VATS) for primary lung tumors between propofol and sevoflurane for the maintenance of anesthesia.

详细描述

Before the scheduled procedure, the patients are randomly assigned into peopofol group or groups (1:1) according to the randomization generated by the computer. Both groups were induced with propofol 1~2.5 mg/kg propofol. The propofol group was maintained at an effect-site concentration of 2.0-4.0 mcg/mL by a target-controlled infusion system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). During the operation, the dose of anesthetic drugs (propofol/fentanyl /remifentanil and sevoflurane/cisatracurium/rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value and Entropy (or BIS) value at 40-60in both groups. The following patient data were recorded, the type of anesthesia, sex, age at the time of surgery, preoperative Karnofsky performance status score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), American Society of Anesthesiologists physical status scores, tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl/ propofol) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, and 3-year overall survival and Karnofsky performance status score were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • eighteen to eighty-year-old
  • ASA class I-III patients
  • Received elective thoracic surgery for primary lung tumors under general anesthesia

排除标准

  • mental disorder
  • poor liver function
  • pregnant or lactating women
  • morbidly obese
  • allergy to any of the drugs used in this study
  • recurrent tumor or repeat surgery
  • biopsy cases
  • incomplete outcome-data
  • palliative treatment after surgery
  • simultaneous treatment of other malignancies
  • emergency surgery
  • presence of other malignant tumors
  • combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine
  • diagnosed as benign lung tumor, or other metastatic lung tumor

研究组 & 干预措施

Sevoflurane

Experimental

The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).

干预措施: Sevoflurane (Drug)

Propofol

Experimental

The propofol group was both induced and maintained at an effect-site concentration (Ce) of 2.0-4.0 mcg/mL by a target-controlled infusion (TCI) system.

干预措施: Propofol (Drug)

结局指标

主要结局

Overall survival

时间窗: From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

6-month overall survival, 1-year overall survival, and 3-year overall survival

The presence of disease progression

时间窗: From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months

From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months

次要结局

  • Postoperative complications(The period from the day of surgery to postoperative 30 days)
  • Length of hospital stays(from the day of surgery to dischage, assessed up to 30 days)
  • Karnofsky performance status score(Karnofsky performance score(from 0 (dead) to 100(normal no complication)) before surgery (baseline data) , postoperation 7 days, postoperation 3 months, postoperation 6 months, postoperation 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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