Clinical Study of the Effect of Methylprednisolone Combined With Two Hydroxypropyl Theophylline on Respiratory Dynamics During Thoracoscopic Lobectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 主要终点
- Pplat
研究概览
简要总结
Through the design of RCT study, the preoperative use of drugs (methylprednisolone + dihydroxypropyltheophylline) as intervention measures, the patients undergoing thoracoscopic lobectomy as the main research object, through the comparison of two groups of patients with intraoperative respiratory dynamics index and postoperative complications, to explore a more effective perioperative management method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •After fully understanding the purpose and significance of the trial, the patients voluntarily participated in the trial and signed the informed consent;
- •The type of operation was general anesthesia and thoracoscopic lobectomy;
- •Age 18-75 years old, including boundary value, gender is not limited;
- •BMI 18-26kg / m2;
- •ASA grade I-II; no mental disorder, normal consciousness, normal communication;
- •No contraindications of methylprednisolone and dihydroxypropyltheophylline.
排除标准
- •There were diseases of immune, endocrine, nervous and mental system before operation, and serious dysfunction of heart, liver and kidney;
- •Take immunosuppressive drugs and non steroidal anti-inflammatory drugs before operation;
- •Respiratory tract infection (cough, expectoration, suffocation, etc.) in recent 1 month; pneumonia, bronchitis, etc. on CT;
- •History of chronic pulmonary disease, including but not limited to asthma, pulmonary abscess, tuberculosis, chronic bronchitis, etc;
- •FEV1 < 50%;
- •Oxygen saturation was lower than 90% and airway pressure was higher than 40 cm H20;
- •Continuous hypotension or hypertension during the operation; intraoperative blood loss > 1000ml;
- •Allergic to methylprednisolone or dihydroxypropyltheophylline;
- •There are any other situations that the researchers think are not suitable for inclusion.
研究组 & 干预措施
Experimental group
干预措施: Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline; (Drug)
control group
干预措施: Placebo (Drug)
结局指标
主要结局
Pplat
时间窗: 5 different time points during the operation
Airway pressure at different time points during operation
Ppeak
时间窗: 5 different time points during the operation
Peak airway pressure at different time points during operation
次要结局
未报告次要终点
研究者
Lili Cao
professor
Qianfoshan Hospital