Clinical Observation of the Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium in Patients With Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 3
- 主要终点
- perioperative opioids consumption
研究概览
简要总结
To observe the effect of preoperative anti-PD-1 monotherapy combined with chemotherapy on patients' perioperative pain and opioid analgesia, and evaluate its effect on the incidence and severity of patients' postoperative delirium.
详细描述
In this study, the investigators intend to select patients with resectable NSCLC treated with immuno-neoadjuvant therapy in combination with chemotherapy, systematically observe the effect of preoperative anti-PD-1 monotherapy on patients' perioperative pain and opioid analgesia, and evaluate its effect on the incidence and severity of patients' postoperative delirium, in order to provide a clinical basis for the perioperative management of patients treated with immuno-neoadjuvant therapy and promote their postoperative recovery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed stage II or stage IIIA non-small cell lung cancer (NSCLC) and meet the requirements for R0 resection;
- •American Society of Anesthesiologists (ASA): I-III, age ≥18 years, body mass index (BMI): 18.5-30;
- •Normal function of Coagulation and vital organs such as heart, lungs, kidney, and liver;
- •Eligible to receive platinum-containing two-drug chemotherapy;
- •Sign the informed consent form
- •Exclusion Criteria
- •Prior treatment of any kind for current lung cancer, including chemotherapy, radiation or targeted therapy;
- •Preoperative opioid analgesia;
- •Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection;
- •History of antipsychotic medication in the last 6 months;
- •Preoperative Mini-mental state examination (MMSE) score <23
排除标准
- 未提供
研究组 & 干预措施
neoadjuvant immunotherapy group
Anti-PD-1 monoclonal antibody (Nivolumab，Pembrolizumab, Sintilimab, or Sugemalimab) 200 mg intravenously in combination with cis-platinum and paclitaxel/pemetrexed
干预措施: neoadjuvant immunotherapy (Drug)
control group
platinum-containing dual-agent chemotherapy(cis-platinum and paclitaxel/pemetrexed)
干预措施: Neoadjuvant chemotherapy (Drug)
结局指标
主要结局
perioperative opioids consumption
时间窗: from beginning of surgery to day 3 after surgery
the amount of sufentanil, remifentanil and morphine application.
次要结局
- postoperative delirium(within 3 days after surgery)
- intraoperative opioid consumption(from the beginning to the end of the surgery)
- Percent of patients with moderate to severe pain within 72 hours(up to 72 hours after surgery)
- analgesic pump press in PICU(day 1, 2 and 3 after surgery)
- score of Numerical Rating Scale(at the time of admission to the operating room, immediately after and at 24 hour, 48 hour, and 72h after entering the PICU)
- postoperative opioid consumption(up to 72 hours after surgery)