Impact of Intraoperative Blood Pressure Management and Dexamethasone on Patient's Outcomes After Lung Cancer Surgery: A 2 × 2 Factorial Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,988
- 试验地点
- 1
- 主要终点
- Overall survival after surgery
研究概览
简要总结
Surgery is the front-line therapy for non-small cell lung cancer (NSCLC) but postoperative complications remains high and patients' long-term outcome is still challenging. In addition to surgery, anesthetic management particularly intraoperative blood pressure management and use of dexamethasone may affect patients' early and long-term outcomes after surgery for NSCLC. This study aims to investigate the impact of intraoperative blood pressure management and dexamethasone administration on early and long-term outcomes in patients undergoing surgery for lung cancer.
详细描述
Surgical resection is the main treatment for patients with non-small cell lung cancer (NSCLC) and continuous efforts have been made to evolve surgical strategies and techniques. It has been now been realized that perioperative period is characterized with profound changes and anesthesia management may also affect outcomes of patients after cancer surgery.
Even under well controlled conditions, blood pressure fluctuation frequently occurs during anesthesia and surgery. In previous studies, intraoperative hypotension was associated with increased risk of organ injuries (such as delirium, acute kidney injury, myocardial injury, and stroke) and higher 1-year mortality. Unpublished data showed that intraoperative hypotension was also associated with shortened long-term survival in patients after lung cancer surgery. In a recent trial, individualized intraoperative blood pressure management which avoided intraoperative hypotension decreased the incidence of postoperative organ injury when compared with routine practice. Avoiding intraoperative hypotension may also prolong survival after lung cancer surgery. However, evidences are lacking regarding this topic.
Dexamethasone is frequently used for prevention of postoperative nausea and vomiting. Studies showed that a single low-dose dexamethasone has anti-inflammatory effect and can regulate immune function. It has been shown that perioperative dexamethasone can improve analgesia after surgery. In retrospective studies, perioperative low-dose dexamethasone was associated with less wound infection and improved long-term survival in patients after surgeries for pancreatic and lung cancer. It is hypothesized that intraoperative dexamethasone may reduce postoperative complications and improve long-term survival after lung cancer surgery. Interventional studies are required to confirm this hypothesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
For dexamethasone administration, all participants, care providers, investigators, and outcomes assessors are masked. For blood pressure management, participants and outcome assessors are masked.
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >50 years but <90 years.
- •Diagnosed as resectable primary non-small cell lung cancer (stage IA-IIIA) and scheduled for radical surgery with an expected duration of >2 hours.
- •Agree to participate in this study and sign the informed consent.
排除标准
- •Clinical examinations suggest non-resectable lung cancer or patients scheduled for a biopsy surgery.
- •Recurrent or metastatic lung cancer.
- •History of cancer or complicated with cancer in other organs.
- •Long-term exposure to glucocorticoids or other immunosuppressant(s) due to autoimmune disease or organ transplantation.
- •Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg); or requirement of vasopressors to maintain blood pressure.
- •Persistent atrial fibrillation, or acute cardiovascular events (acute coronary syndrome, stroke, or congestive heart failure) within 3 months.
- •Severe hepatic dysfunction (Child-Pugh C) or renal failure (requirement of renal replacement therapy).
- •Any other circumstances considered unsuitable for study participation by attending physicians or investigators.
研究组 & 干预措施
Routine blood pressure management + placebo
Blood pressure is maintained according to routine practice. Placebo (normal saline 2 ml) is administered before anesthesia induction.
干预措施: Placebo (Drug)
Routine blood pressure management + placebo
Blood pressure is maintained according to routine practice. Placebo (normal saline 2 ml) is administered before anesthesia induction.
干预措施: Routine blood presure management (Other)
Routine blood pressure management + dexamethasone
Blood pressure is maintained according to routine practice. Dexamethasone (10 mg/2 ml) ia administered before anesthesia induction.
干预措施: Dexamethasone (Drug)
Routine blood pressure management + dexamethasone
Blood pressure is maintained according to routine practice. Dexamethasone (10 mg/2 ml) ia administered before anesthesia induction.
干预措施: Routine blood presure management (Other)
Targeted blood pressure management + placebo
Blood pressure is maintained within ±10% from baseline. Placebo (normal saline 2 ml) is administered before anesthesia induction.
干预措施: Targeted blood pressure management (Other)
Targeted blood pressure management + placebo
Blood pressure is maintained within ±10% from baseline. Placebo (normal saline 2 ml) is administered before anesthesia induction.
干预措施: Placebo (Drug)
Targeted blood pressure management + dexamethasone
Blood pressure is maintained within ±10% from baseline. Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.
干预措施: Dexamethasone (Drug)
Targeted blood pressure management + dexamethasone
Blood pressure is maintained within ±10% from baseline. Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.
干预措施: Targeted blood pressure management (Other)
结局指标
主要结局
Overall survival after surgery
时间窗: Up to 5 years after surgery
Overall survival after surgery
Incidence of organ injury and complications within 5 days after surgery (sub-study).
时间窗: Up to 5 days after surgery.
Organ injury includes delirium, acute kidney injury and myocardial injury. Postoperative complications are generally defined as newly occurred medical conditions that are harmful to patients' recovery and required therapeutic intervention, i.e., grade II or above on the Clavien-Dindo classification.
次要结局
- Recurrence-free survival after surgery(Up to 5 years after surgery)
- Cancer-specific survival after surgery(Up to 5 years after surgery)
- Event-free survival after surgery(Up to 5 years after surgery)
- Rate of intensive care unit (ICU) admission after surgery (sub-study)(During the day of surgery)
- Length of stay in ICU after surgery (sub-study)(Up to 30 days after surgery)
- Incidence of complications within 30 days after surgery (sub-study)(Up to 30 days after surgery)
- Rate of 30-day all-cause mortality (sub-study)(Up to 30 days after surgery)
- Rate of ICU admission with endotracheal intubation after surgery (sub-study)(During the day of surgery)
- Duration of mechanical ventilation in ICU after surgery (sub-study)(Up to 30 days after surgery)
- Incidence of organ injury within 5 days after surgery (sub-study)(Up to 5 days after surgery)
- Length of stay in hospital after surgery (sub-study)(Up to 30 days after surgery)
研究者
Dong-Xin Wang
Chairman, Department of Anaesthesiology and Critical Care Medicine
Peking University First Hospital