Impact of inhalational versus intravenous anaesthesia on early delirium and long-term survival in elderly patients after cancer surgery: study protocol of a multicentre, open-label, and randomised controlled trial
机构:[1]Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China[2]Project Development and Project Management Department, Peking University Clinical Research Institute, Beijing, China[3]Department of Anesthesiology, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China临床科室麻醉科河北医科大学第四医院[4]Department of Anesthesiology, Tang-Du Hospital Fourth Military Medical University, Xi'an, Shaanxi, China[5]Department of Anesthesiology, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, Guangxi Zhuang Autonomous Region, China[6]Department of Anesthesiology, Ningxia People’s Hospital, Yinchuan, Ningxia Hui Autonomous Region, China[7]Department of Anesthesiology, The Third Xiangya Hospital Central South University, Changsha, Hunan, China[8]Department of Anesthesiology, Qinghai University Affiliated Hospital, Xining, Qinghai, China[9]Department of Anesthesiology, Guizhou Provincial People’s Hospital, Guiyang, Guizhou, China[10]Department of Anesthesiology, Shanxi Provincial People’s Hospital, Taiyuan, Shanxi, China[11]Department of Anesthesiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China[12]Department of Anesthesiology, Beijing Shijitan Hospital, Beijing, China[13]Department of Anesthesiology, Peking University Hospital of Stomatology, Beijing, China[14]Department of Anesthesiology, Shanxi Provincial Cancer Hospital, Taiyuan, Shanxi, China[15]Department of Anesthesiology, Southeast University Zhongda Hospital, Nanjing, Jiangsu, China[16]Department of Anesthesiology, Peking University Cancer Hospital&Institute, Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education), Beijing, Beijing, China[17]Department of Anesthesiology, Shenzhen Second People’s Hospital, Shenzhen, Guangzhou, China深圳市康宁医院深圳医学信息中心[18]Department of Anesthesiology, Tianjin Nankai Hospital, Tianjin, China[19]Department of Surgery and Cancer, Anaesthetics, Pain Medicine and Intensive Care Section, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital, London, UK
Introduction Elderly patients who have solid organ cancer often receive surgery. Some of them may develop delirium after surgery and delirium development is associated with worse outcomes. Furthermore, despite all of the advances in medical care, the long-term survival in cancer patients is far from optimal. Evidences suggest that choice of anaesthetics during surgery, that is, either inhalational or intravenous anaesthetics, may influence outcomes. However, the impact of general anaesthesia type on the occurrence of postoperative delirium is inconclusive. Although retrospective studies suggest that propofol-based intravenous anaesthesia was associated with longer survival after cancer surgery when compared with inhalational anaesthesia, prospective studies as such are still lacking. The purposes of this randomised controlled trial are to test the hypotheses that when compared with sevoflurane-based inhalational anaesthesia, propofol-based intravenous anaesthesia may reduce the incidence of early delirium and prolong long-term survival in elderly patients after major cancer surgery. Methods and analysis This is a multicentre, open-label, randomised controlled trial with two parallel arms. 1200 elderly patients (>= 65 years but < 90 years) who are scheduled to undergo major cancer surgery (with predicted duration >= 2 hours) are randomised to receive either sevoflurane-based inhalational anaesthesia or propofol-based intravenous anaesthesia. Other anaesthetics and supplemental drugs including sedatives, opioids and muscle relaxants are administered in both arms according to routine practice. The primary early outcome is the incidence of 7-day delirium after surgery and the primary long-term outcome is the duration of 3-year survival after surgery. Ethics and dissemination The study protocol has been approved by the Clinical Research Ethics Committees of Peking University First Hospital (2015[869]) and all participating centres. The results of early and long-term outcomes will be analysed and reported separately.
基金:
Wu Jieping Medical Foundation, Beijing, China [320.6750.15175]; Chinese Society of Cardiothoracic and Vascular Anesthesiology, Beijing, China
第一作者机构:[1]Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China
通讯作者:
通讯机构:[1]Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China
推荐引用方式(GB/T 7714):
Zhang Yue,Li Hui-Juan,Wang Dong-Xin,et al.Impact of inhalational versus intravenous anaesthesia on early delirium and long-term survival in elderly patients after cancer surgery: study protocol of a multicentre, open-label, and randomised controlled trial[J].BMJ OPEN.2017,7(11):doi:10.1136/bmjopen-2017-018607.
APA:
Zhang, Yue,Li, Hui-Juan,Wang, Dong-Xin,Jia, Hui-Qun,Sun, Xu-De...&Ma, Daqing.(2017).Impact of inhalational versus intravenous anaesthesia on early delirium and long-term survival in elderly patients after cancer surgery: study protocol of a multicentre, open-label, and randomised controlled trial.BMJ OPEN,7,(11)
MLA:
Zhang, Yue,et al."Impact of inhalational versus intravenous anaesthesia on early delirium and long-term survival in elderly patients after cancer surgery: study protocol of a multicentre, open-label, and randomised controlled trial".BMJ OPEN 7..11(2017)