Efficacy and Safety of Non-intubated Versus Intubated Anesthesia in Thoracoscopic Radical Esophagectomy for Esophageal Cancer: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- Incidence of intraoperative and postoperative complications
研究概览
简要总结
This is a prospective, single-center, non-inferiority randomized controlled trial designed to evaluate the perioperative safety and feasibility of non-intubated spontaneous ventilation anesthesia (NIV) compared to conventional intubated mechanical ventilation anesthesia (IMV) in patients undergoing thoracoscopic esophagectomy for esophageal cancer. The study will be conducted at the First Affiliated Hospital of Guangzhou Medical University and aims to assess whether the non-intubated approach can offer comparable or better outcomes in terms of intraoperative and postoperative complications, anesthetic drug consumption, recovery parameters, and overall postoperative rehabilitation.
Eligible patients aged 18 to 75 years with resectable middle or lower thoracic esophageal squamous cell carcinoma or adenocarcinoma (stage I-III) will be randomly assigned (1:1) to receive either NIV using a laryngeal mask airway or IMV with a double-lumen endotracheal tube. Both groups will undergo the same thoracoscopic and laparoscopic surgical procedures, and anesthesia will be managed with standardized protocols. The primary outcome is the incidence of intraoperative and postoperative complications, including hypoxemia, hypercapnia, respiratory failure, and the need for conversion to intubation. Secondary outcomes include anesthetic drug dosage, intraoperative hemodynamic stability, postoperative pain scores, time to ambulation, length of hospital stay, and 30-day readmission rate.
This trial complies with the Declaration of Helsinki. Written informed consent will be obtained from all participants prior to enrollment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Diagnosed with resectable middle or lower thoracic esophageal squamous cell carcinoma or adenocarcinoma (clinical stage I-III)
- •Scheduled to undergo thoracoscopic esophagectomy
- •American Society of Anesthesiologists (ASA) score ≤ III
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- •Preoperative pulmonary function test with FEV₁ ≥ 50% predicted
- •Written informed consent obtained
排除标准
- •Severe risk of aspiration due to reflux, gastric retention, or hiatal hernia
- •Body mass index (BMI) ≥ 30 kg/m²
- •Extensive pleural adhesions discovered preoperatively
- •History of upper thoracic or intrathoracic surgery
- •Pregnancy or lactation
- •Known allergy or intolerance to anesthetic agents
研究组 & 干预措施
Non-intubated
干预措施: Non-intubated spontaneous ventilation anesthesia (Procedure)
Intubated
结局指标
主要结局
Incidence of intraoperative and postoperative complications
时间窗: From anesthesia induction to 30 days postoperatively
Composite incidence of complications occurring intraoperatively or within 30 days after surgery, including hypoxemia (SpO₂ \< 90% for \>1 minute), hypercapnia (PaCO₂ ≥ 65 mmHg), conversion to intubation (in the non-intubated group), severe arrhythmia, hemodynamic instability, postoperative pulmonary infection, anastomotic leakage, bleeding, pneumothorax, respiratory failure, and reintubation.
次要结局
未报告次要终点
研究者
Jianxing He
head of Guangzhou Institude of respiratory health
The First Affiliated Hospital of Guangzhou Medical University