Comparison of the effect of high versus low mean arterial pressure levels on clinical outcomes and complications in elderly patients during non-cardiothoracic surgery under general anesthesia: study protocol for a randomized controlled trial

Springer Science and Business Media LLC - Tập 18 - Trang 1-8 - 2017
Anmin Hu1,2,3, Yan Qiu4, Peng Zhang5, Bailong Hu6, Yali Yang7, Shutao Li8, Rui Zhao9, Zhongjun Zhang1,2,3, Yaoxian Zhang1,2,3, Zihao Zheng1,2,3, Chen Qiu10, Furong Li10, Xiaolei Gong10
1Department of Anesthesiology, Shenzhen People's Hospital, Shenzhen, China
2Shenzhen Anesthesiology Engineering Center, Shenzhen, China
3The Second Clinical Medical College, Jinan University, Shenzhen, China
4Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China
5Department of Anesthesiology, Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital, Chengdu, China
6Department of Anesthesiology, Affiliated Hospital of Guizhou Medical University, Guiyang, China
7Department of Anesthesiology, Henan Provincial People’s Hospital of Zhengzhou University, Zhengzhou, China
8Department of Anesthesiology, Taihe Hospital of Hubei University of Medicine, Shiyan, People’s Republic of China
9Department of Anesthesiology, The Third Affiliated Hospital of Kunming Medical University, Kunming, China
10Clinical Medical Research Center, The Second Clinical Medicine College, Jinan University, Shenzhen, China

Tóm tắt

Intraoperative blood pressure (BP) is a concern in daily clinic anesthesia and contributes to the differences in clinical outcome. We conducted a randomized controlled trial (RCT) to compare the effect of high vs. low mean arterial pressure (MAP) levels on clinical outcomes and complications in elderly patients under general anesthesia (GA). In this multicenter, randomized, parallel-controlled, open-label, assessor-blinded clinical trial, 322 patients aged more than 65 years will be randomized for a low-level MAP (60–70 mmHg) or high-level MAP (90–100 mmHg) during non-cardiothoracic surgery under GA. The primary outcome will be the incidence of postoperative delirium. The secondary outcomes will include the delirium duration days, intraoperative urine volume, intraoperative blood loss, specific postoperative complications, and all-cause 28-day mortality. Results of this trial will help clarify whether BP management is beneficial for elderly patients under GA and will make clear whether the effect of high-level MAP can reduce the postoperative complication compared to low-level MAP. ClinicalTrials.gov, NCT02857153 . Registered on 15 July 2016.

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