Total Intravenous Anesthesia Versus Balanced Anesthesia on Loss of Muscle Mass After Colorectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ultrasonographic assessment of muscle mass
研究概览
简要总结
This study is aimed at clarifying changes in body composition during the perioperative period and identifying risk factors for skeletal muscle mass loss in patients with colorectal cancer. The investigators will asess the impact of the type of anaesthesia (total intravenous anaesthesia/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass, which will be evaluated using ultrasound, dynamometry and bioimpedance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients diagnosed with colorectal cancer and scheduled for open colorectal surgery at the Regional Institute of Oncology, Iaşi, Romania
排除标准
- •lack the capacity to consent
- •extremity amputation
- •paraplegia
- •diseases affecting the muscles (such as stroke, lower-limb immobilization from a plaster, neurodegenerative diseases, peripheral neuropathy or muscle dystrophy)
- •terminal cancer
结局指标
主要结局
Ultrasonographic assessment of muscle mass
时间窗: From enrollment to 5 days after surgery
Ultrasonographic muscle assessment is standardised in the assessment of muscle according to the SARCUS (Sarcopenia through UltraSound) working group recommendations. Rectus femoris muscle will be evaluated at 50% distance between the anterior superior iliac spine and the superior pole of the patella, in a lying position with knees in 10°, for muscle thickness and muscle cross-sectional area (CSA). Three measurements will be taken for each data point, and the average value will be used for further analysis. The biceps brachii muscle will be evaluated at 50% distance acromioclavicular joint and the elbow crease, in a supine position. Muscle thickness can be easily defined as the maximal vertical distance between the superficial and deep fasciae.
Muscle function assessment
时间窗: From enrollment to 5 days after surgery
Measuring grip strength is simple and inexpensive. Grip strength will be determined bilaterally. Each measurement will be performed three times on the left and right extremities with 20 seconds intervals between the measurements. The maximum measured value in kilograms will be used for analysis.
Bioimpedance assessment of lean and fat tissue mass
时间窗: From enrollment to 5 days after surgery
The bioimpedance measurements will be performed by a trained operator according to the manufacturer's recommendations. The Body Composition Monitor provides a quantitative measure of lean tissue and fat tissue mass. In contrast to earlier bioimpedance methodologies, the bioimpedance spectroscopy expresses body composition as a three-compartment model, providing overhydration, lean tissue index (LTI), and fat tissue index (FTI), whereby LTI and FTI are the respective tissue masses normalized to height squared.
次要结局
- Hospital length of stay(From enrollment to the patient discharge, up to 52 weeks)
- Mortality(28 and 90-day mortality after surgery)
研究者
Ianis Siriopol
Lecturer
Grigore T. Popa University of Medicine and Pharmacy