Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Number of the patients with productive cough and difficult expectoration
研究概览
简要总结
The goals of this study were to investigate whether two anesthesia regimens, with and without N2O, and bacterial colonization influence respiratory complications after major abdominal surgery for cancer.
详细描述
A study was approved by institutional ethics committee. All patients were informed on the study protocol by attending anesthesiologist on the day of the surgery and written informed consent was obtained. Patients with clinically or radiologically confirmed acute respiratory infections or those using antibiotics due to the respiratory infections a week prior to the surgery were not included in the study. Following risk factors were recorded in all patients: age, sex, weight loss in the last 6 months, comorbidities and operative time. Comorbidities were rated using ASA status and Charlson comorbidity index by 3 independent observers. Charlson comorbidity index was calculated after pathological examination. An advanced malignant disease was considered if tumor had infiltrated other organs or surrounding tissues, or when positive lymph nodes or metastases were confirmed.
A group of 120 colorectal, gastric, or pancreatic cancer patients scheduled for surgery in the single centre were included in the prospective randomized study regardless of their ASA physical status. Nasopharyngeal smears were obtained in the preoperative area and tracheal aspirates were obtained in the operating room at the end of the surgery with a sterile suction catheter in a closed system.
Postoperative Hgb; CRP and lung auscultation were done in all patients on the second and fourth postoperative day.
Outcome measures registered were:
- Postoperative pneumonia
- Productive and difficult cough
- Dysphonia
- Congestive heart failure
- postoperative complications, including hypertensive crisis, thromboembolic and infective complications were summarized one year after surgical treatment was finished & one year survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Postoperative outcomes were registered by doctor who did not know type of anesthesia delivered
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients diagnosis of gastric cancer, or colorectal cancer or pancreatic cancer
- •Scheduled for major abdominal surgery with organ resections
- •Written informed consent
- •Nasopharyngeal smears taken in the preoperative area
- •Tracheal aspirates taken at the end of the surgical procedure
排除标准
- •Patients unable to understand study protocol and patients who refused study participation at any time
- •patients with clinically or radiologically confirmed acute respiratory infections at admission
- •antibiotic therapy due to the respiratory infections a week prior to the surgery
研究组 & 干预措施
Group air
Group air was mechanically ventilated using 35% oxygen in 65% air during the whole surgical procedure.
Thiopental sodium was used for induction of anesthesia, muscle relaxation was maintained with vecuronium. General anesthesia with sevoflurane was maintained during the surgical procedure. Intraoperative analgesia was achieved with fentanyl boluses.
干预措施: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients. (Other)
Group nitrous oxyde (N2O)
Group N2O was mechanically ventilated using 35 % oxygen and 65 % of nitrous oxyde during the surgical procedure.
Nitrous oxyde may increase cuff pressure during the general endotracheal anesthesia and result in the respiratory symptoms like sore throat, hoarseness and postoperative cough.
Thiopental sodium was used for induction of anesthesia, muscle relaxation was maintained with vecuronium. General anesthesia with sevoflurane was maintained during the surgical procedure. Intraoperative analgesia was achieved with fentanyl boluses.
干预措施: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients. (Other)
结局指标
主要结局
Number of the patients with productive cough and difficult expectoration
时间窗: Postoperative day 4
patients without auscultatory findings who self reported that they have productive sputum and painful expectoration without laboratory and RTG findings suggestive for pneumonia
Number of the patients with postoperative pneumonia
时间窗: Postoperative day 4
Number of patients who reported the presence of cough, dyspnea and/or abnormal findings on lung examination, and two of following: fever, leukocytosis or high CRP, and positive chest radiograms.
Number of the patients with hoarseness
时间窗: Postoperative day 4
The patients who self-reported hoarseness and changed voice
次要结局
- One year survival and complications(One postoperative year)