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  • 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

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Anaesthesia
Protocol
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
  1. Yue Zhang1,
  2. Hui-Juan Li2,
  3. Dong-Xin Wang1,
  4. Hui-Qun Jia3,
  5. Xu-De Sun4,
  6. Ling-Hui Pan5,
  7. Qing-Shan Ye6,
  8. Wen Ouyang7,
  9. Zhen Jia8,
  10. Fang-Xiang Zhang9,
  11. Yong-Qing Guo10,
  12. Yan-Qiu Ai11,
  13. Bin-Jiang Zhao12,
  14. Xu-Dong Yang13,
  15. Qin-Gong Zhang14,
  16. Ning Yin15,
  17. Hong-Yu Tan16,
  18. Zhi-Heng Liu17,
  19. Jian-Bo Yu18,
  20. Daqing Ma19
  1. 1 Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China
  2. 2 Project Development and Project Management Department, Peking University Clinical Research Institute, Beijing, China
  3. 3 Department of Anesthesiology, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
  4. 4 Department of Anesthesiology, Tang-Du Hospital Fourth Military Medical University, Xi’an, Shaanxi, China
  5. 5 Department of Anesthesiology, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, Guangxi Zhuang Autonomous Region, China
  6. 6 Department of Anesthesiology, Ningxia People’s Hospital, Yinchuan, Ningxia Hui Autonomous Region, China
  7. 7 Department of Anesthesiology, The Third Xiangya Hospital Central South University, Changsha, Hunan, China
  8. 8 Department of Anesthesiology, Qinghai University Affiliated Hospital, Xining, Qinghai, China
  9. 9 Department of Anesthesiology, Guizhou Provincial People’s Hospital, Guiyang, Guizhou, China
  10. 10 Department of Anesthesiology, Shanxi Provincial People’s Hospital, Taiyuan, Shanxi, China
  11. 11 Department of Anesthesiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
  12. 12 Department of Anesthesiology, Beijing Shijitan Hospital, Beijing, China
  13. 13 Department of Anesthesiology, Peking University Hospital of Stomatology, Beijing, China
  14. 14 Department of Anesthesiology, Shanxi Provincial Cancer Hospital, Taiyuan, Shanxi, China
  15. 15 Department of Anesthesiology, Southeast University Zhongda Hospital, Nanjing, Jiangsu, China
  16. 16 Department of Anesthesiology, Peking University Cancer Hospital&Institute, Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education), Beijing, Beijing, China
  17. 17 Department of Anesthesiology, Shenzhen Second People’s Hospital, Shenzhen, Guangzhou, China
  18. 18 Department of Anesthesiology, Tianjin Nankai Hospital, Tianjin, China
  19. 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
  1. Correspondence to Dr Dong-Xin Wang; wangdongxin{at}hotmail.com

Abstract

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.

Trial registration number ChiCTR-IPR-15006209; NCT02662257; NCT02660411.

  • cancer
  • surgery
  • survival
  • anaesthesia in oncology

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-018607

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    Footnotes

    • Contributors D-XW: conceived the study and is the principal investigator and has overall responsibility for the trial. YZ and D-XW: drafted the protocol. H-JL: revised the parts of data management and statistical analysis. H-QJ, Q-SY, L-HP, WO, ZJ, X-DS, F-XZ, Y-QG, Q-GZ, X-DY, H-YT, B-JZ, Y-QA, NY, Z-HL, J-BY and DM: participated in the study design and coordination of the study. All authors: read and approved the final manuscript.

    • Funding This study is supported by grants from the Wu Jieping Medical Foundation, Beijing, China (320.6750.15175) and the Chinese Society of Cardiothoracic and Vascular Anesthesiology, Beijing, China. The study sponsors have no role in study design, in the collection, analysis, and interpretation of data, in the writing of the report, or in the decision to submit the report for publication. The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the Wu Jieping Medical Foundation or the Chinese Society of Cardiothoracic and Vascular Anesthesiology.

    • Competing interests DXW is supported by grants from the Wu Jieping Medical Foundation(320.6750.15175), China and the Chinese Society of Cardiothoracic and Vascular Anesthesiology, China; he reports lecture fees and travel expenses for lectures from Jiangsu Hengrui Medicine Co Ltd, China, Yichang Humanwell Pharmaceutical Co Ltd, China, and Jiangsu Nhwa Pharmaceutical Co Ltd, China. DM is supported by grants from the British Oxygen Chair, and British Journal of Anaesthesia Fellowship, London, UK.

    • Patient consent Obtained.

    • Ethics approval The study protocol has been approved by the Clinical Research Ethics Committee of the Peking University First Hospital (first version protocol approved on 13 April 2015 with number 2015[869]) and the Ethics Committees of all participating centers. Any revision of the study protocol must be approved by the Ethics Committee before it can be executed in the study.

    • Provenance and peer review Not commissioned; externally peer reviewed.