Effects of Different Anesthetic Techniques on Intraoperative and Postoperative Pain Levels and Cognitive Function in Patients Undergoing Hepatectomy for Liver Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Postoperative Cognitive Dysfunction (POCD)
研究概览
简要总结
To evaluate the effects of general anesthesia (GA) versus combined general and epidural anesthesia (GEA) on postoperative pain, cognitive dysfunction (POCD), hospital stay, and recovery quality in liver cancer patients undergoing hepatectomy.
A retrospective analysis of 80 liver cancer patients was conducted, categorized by analgesic adequacy, pain recovery, and POCD incidence: adequate vs. inadequate analgesia (n=50 vs. n=30), favorable vs. delayed pain recovery (n=36 vs. n=44), and POCD vs. non-POCD (n=42 vs. n=38). Based on these results, a prospective study (April 2024-April 2025) enrolled patients scheduled for elective hepatectomy, assigned to the GA group (n=59) or GEA group (n=47). Primary outcomes included intraoperative analgesic consumption, postoperative VAS pain scores, MoCA cognitive scores, hospital stay length, and adverse event rates.
详细描述
Compared to GA alone, combined epidural-general anesthesia provides better perioperative pain control, reduces POCD risk, shortens hospitalization, and enhances recovery. GEA is a preferable anesthetic approach for liver cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or radiologically confirmed primary liver cancer (HCC or cholangiocarcinoma)
- •Scheduled for elective open or laparoscopic radical hepatectomy
- •Age 18-75 years
- •ASA Physical Status I-III
- •Child-Pugh class A or B liver function
- •Normal preoperative MoCA score (≥26)
- •Willing to participate and provide informed consent
排除标准
- •Severe cardiovascular, pulmonary or renal disease (ASA IV/V)
- •Chronic pain disorders or preoperative opioid use (>3 months)
- •Known neurologic/psychiatric conditions (dementia, stroke, epilepsy)
- •Concurrent major procedures (e.g., vascular resection)
- •Intraoperative conversion to palliative surgery
- •Massive intraoperative hemorrhage (>2000 mL)
- •Coagulopathy (INR >1.5 or platelets <50×10⁹/L)
- •Spinal abnormalities precluding epidural catheterization
- •Pregnancy or lactation
- •Allergy to local anesthetics or study medications
研究组 & 干预措施
general anesthesia group
In the General Anesthesia (GA) group (n = 59), patients received combined intravenous-inhalation general anesthesia. Anesthesia induction was performed using propofol and remifentanil, followed by maintenance with sevoflurane to ensure adequate anesthetic depth and hemodynamic stability throughout the procedure.
干预措施: General Anesthesia (GA) group (Drug)
General-Epidural Anesthesia group
In the General-Epidural Anesthesia (GEA) group (n = 47), patients received the same general anesthesia protocol as the GA group, in addition to epidural anesthesia. An epidural catheter was placed preoperatively at the T7-T9 vertebral level using a midline approach under strict aseptic conditions. Following successful catheterization and confirmation of proper placement, a continuous intraoperative infusion of 0.25% ropivacaine was administered via the epidural route to provide segmental analgesia and reduce intraoperative opioid requirements.
干预措施: General-Epidural Anesthesia (GEA) group (Drug)
结局指标
主要结局
Postoperative Cognitive Dysfunction (POCD)
时间窗: Baseline (preoperative), POD1 (24±4h), POD3 (72±6h)
Percentage of patients with: MoCA score \<26 at postoperative assessment OR ≥2-point decrease from preoperative baseline (Assessed using Montreal Cognitive Assessment, 30-point scale)
Postoperative Pain Intensity
时间窗: 2h, 6h, 12h, 24h, 48h postoperatively
Mean pain scores measured by: Visual Analog Scale (VAS) 10cm scale (0=no pain, 10=worst pain)
次要结局
- Intraoperative Opioid Consumption(Anesthesia induction to extubation)
- Hospital Length of Stay(Up to 30 days post-surgery)
- Adverse Event Incidence(0-72 hours postoperatively)
研究者
Juhui Chen
Principal Investigator
Sir Run Run Shaw Hospital