The Effects of Sarcopenia on Neuromuscular Block in Gastrointestinal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Onset Time of Neuromuscular Block
研究概览
简要总结
This prospective observational study aims to evaluate the effects of sarcopenia on intraoperative neuromuscular block (NMB) in patients undergoing gastrointestinal cancer surgery. Adult patients scheduled for elective gastrointestinal cancer surgery will be grouped as sarcopenic or non-sarcopenic based on preoperative abdominal CT scans. Neuromuscular block parameters, including onset time, depth, duration, and recovery, will be objectively measured using TOF (Train-of-Four) monitoring. The study seeks to determine whether sarcopenia influences sensitivity to muscle relaxants and to contribute to individualized anesthesia management and patient safety.
详细描述
Sarcopenia, characterized by the loss of skeletal muscle mass and function, is a significant clinical parameter affecting both prognosis and perioperative management in patients with gastrointestinal (GI) cancer. It may alter the pharmacokinetic and pharmacodynamic properties of anesthetic agents, particularly neuromuscular blocking agents. This prospective observational study will be conducted at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between June 1, 2025, and September 1, 2025.
Adult patients (aged 18 and above) scheduled for elective GI cancer surgery who have undergone preoperative abdominal computed tomography (CT) will be included. Patients with neuromuscular diseases, those on chronic steroid or immunosuppressive therapy, or those with significant organ failure will be excluded. Preoperative CT images at the L3 vertebral level will be evaluated by a radiologist to determine sarcopenia status, and patients will be divided into sarcopenic and non-sarcopenic groups according to established cut-off values.
All patients will receive standard anesthesia monitoring, including TOF (Train-of-Four) neuromuscular monitoring. The study will not alter any treatment protocols. After administration of muscle relaxants during anesthesia induction, neuromuscular block parameters such as onset time, depth, duration, need for reversal agents, and recovery time will be recorded. Demographic data, comorbidities, laboratory findings, type of surgery, and details of muscle relaxant use will also be collected.
The primary objective is to compare intraoperative neuromuscular block parameters between sarcopenic and non-sarcopenic patients. Statistical analysis will be performed using appropriate parametric or non-parametric tests for continuous variables and chi-square tests for categorical variables. The study aims to provide evidence for individualized dosing of muscle relaxants and to improve patient safety in anesthesia practice for GI cancer surgery.
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 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 18 and 75 years
- •Patients diagnosed with gastrointestinal system (GIS) cancer and scheduled for elective surgery
- •Patients who have undergone preoperative abdominal computed tomography (CT) imaging
- •Patients classified as American Society of Anesthesiologists (ASA) physical status I-III
排除标准
- •Patients with a history of neuromuscular diseases
- •Patients receiving chronic steroid or immunosuppressive therapy
- •Patients with electrolyte imbalance
- •Patients using medications that affect neuromuscular transmission
- •Patients with severe organ failure in the preoperative period (e.g., liver or renal failure)
- •Patients who refuse to participate in the study
- •Patients requiring emergency surgery
- •Patients using muscle relaxants in the preoperative period
研究组 & 干预措施
Non-Sarcopenic
Patients with gastrointestinal cancer scheduled for elective surgery who are identified as non-sarcopenic based on preoperative abdominal CT scans at the L3 vertebral level, according to established cut-off values.
干预措施: Standard Anesthesia Management (Procedure)
Sarcopenic
Patients with gastrointestinal cancer scheduled for elective surgery who are identified as sarcopenic based on preoperative abdominal CT scans at the L3 vertebral level, according to established cut-off values.
干预措施: Standard Anesthesia Management (Procedure)
结局指标
主要结局
Onset Time of Neuromuscular Block
时间窗: Intraoperative (from induction until adequate block is achieved)
Time from administration of the muscle relaxant to achievement of adequate neuromuscular block, measured by Train-of-Four (TOF) monitoring.
Depth of Neuromuscular Block (TOF Ratio)
时间窗: Intraoperative (from induction to end of surgery)
Intraoperative depth of neuromuscular block, continuously monitored using TOF ratio.
Duration of Neuromuscular Block
时间窗: Intraoperative (from muscle relaxant administration to recovery)
Time from administration of the muscle relaxant to recovery of neuromuscular function (TOF ratio ≥ 0.9).
Dose and Duration of Reversal Agent
时间窗: Intraoperative (from administration of reversal agent to recovery)
Total dose and time required for the reversal agent to achieve recovery from neuromuscular block.
次要结局
未报告次要终点
研究者
Mustafa Kemal ŞAHİN
Principal Investigator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital