A Prospective Observational Study on the Effects of Anesthesia Techniques on Tissue Oxygenation and Postoperative Recovery in Lower Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Tissue Oxygenation Levels Measured by NIRS
研究概览
简要总结
This is a prospective observational study designed to evaluate the effects of different anesthesia techniques on tissue oxygenation and postoperative recovery in patients undergoing lower abdominal surgery. A total of 180 patients will be enrolled and evenly allocated into four groups based on the anesthesia method used: general anesthesia, spinal anesthesia, epidural anesthesia, and combined general plus epidural anesthesia.
Near-infrared spectroscopy (NIRS) will be utilised to monitor tissue oxygenation at the thenar and plantar regions during the perioperative period. Vital signs, VAS scores(min 0-max 10 points), Quality of Recovery-40 (QoR-40) scores(min 40-max 200 points), and additional postoperative recovery parameters- including length of stay in the post-anesthesia care unit and hospital, surgical site infection, wound revision, and mortality- will be recorded and compared across the groups.
The primary hypothesis is that regional anesthesia techniques enchance tissue oxygenation and are associated with improved postoperative recovery outcomes compared to general anesthesia alone. The study was approved by the local ethics committee and will be conducted at a single tertiary-care center.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Days 至 80 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 years
- •Scheduled for elective lower abdominal surgery
- •Eligible for general, spinal, epidural or combined anesthesia techniques
- •Provided writen informed consent
- •ASA physical status 1-3
排除标准
- •Refusal to participate
- •Emergency surgery
- •Severe cardiovascular or respiratory instability
- •Pre-existing severe cognitive impairment of communication barrier
- •Peripheral vascular disease affecting NIRS readind
- •Local infection or anatomical anomaly preventing regional anesthesia
结局指标
主要结局
Tissue Oxygenation Levels Measured by NIRS
时间窗: From baseline(pre-op) to end of surgery
Continuous measurement of tissue oxygenation at thenar and plantar sites using near-infrared spectroscopy during perioperative period
次要结局
- Intraoperative Vital Signs(Intraoperative period)
- Visual Analog Scale(VAS) Pain Scores(Up to 24 hours after surgery)
- Qor-40 Questionnaire Scores(postoperative day 1)
研究者
Ars Gor Dr Edip Gules
Research Assistant-Anestesthesiology and Reanimation
Trakya University