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Clinical Trial
. 2017 Nov 28;7(11):e018607.
doi: 10.1136/bmjopen-2017-018607.

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

Yue Zhang  1 , Hui-Juan Li  2 , Dong-Xin Wang  1 , Hui-Qun Jia  3 , Xu-De Sun  4 , Ling-Hui Pan  5 , Qing-Shan Ye  6 , Wen Ouyang  7 , Zhen Jia  8 , Fang-Xiang Zhang  9 , Yong-Qing Guo  10 , Yan-Qiu Ai  11 , Bin-Jiang Zhao  12 , Xu-Dong Yang  13 , Qin-Gong Zhang  14 , Ning Yin  15 , Hong-Yu Tan  16 , Zhi-Heng Liu  17 , Jian-Bo Yu  18 , Daqing Ma  19
Affiliations
Clinical Trial

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

Yue Zhang et al. BMJ Open. .

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.

Keywords: anaesthesia in oncology; cancer; surgery; survival.

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Conflict of interest statement

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.

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Figure 1
Flowchart of the study.
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