Effect of rScO2-Guided Blood Pressure Management on Postoperative Complications in Elderly Patients After Major Noncardiac Surgery: Protocol for a Randomized Controlled Trial

Yu-Fan Yang; Lin-Lin Liu; Ming-Jie Huang; Zheng-Min Ma; Wen-Wen Huo; Ya-Juan Zhu; Hong Liu; Ke Peng; Fu-Hai Ji

doi:10.2147/IJGM.S426245

Effect of rScO₂-Guided Blood Pressure Management on Postoperative Complications in Elderly Patients After Major Noncardiac Surgery: Protocol for a Randomized Controlled Trial

Int J Gen Med. 2023 Aug 25:16:3789-3796. doi: 10.2147/IJGM.S426245. eCollection 2023.

Authors

Yu-Fan Yang^#^{1

2}, Lin-Lin Liu^#^{1

2}, Ming-Jie Huang^#^{1

2}, Zheng-Min Ma^{1

2}, Wen-Wen Huo^{1

2}, Ya-Juan Zhu^{1

2}, Hong Liu³, Ke Peng^{1

2}, Fu-Hai Ji^{1

2}

Affiliations

¹ Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, People's Republic of China.
² Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, People's Republic of China.
³ Department of Anesthesiology and Pain Medicine, University of California Davis Health, Sacramento, CA, USA.

^# Contributed equally.

Abstract

Background: Postoperative complications are common after major surgical procedures, leading to increased morbidity and mortality. Regional cerebral oxygen saturation (rScO₂) reflects cerebral and global perfusion, and thus it can be used to guide hemodynamic management. We aim to explore the effect of rScO₂-guided blood pressure management strategy on postoperative major complications in older adults who undergo major noncardiac surgery.

Methods: This randomized controlled clinical trial includes a total of 400 elderly patients receiving major noncardiac surgery and general anesthesia. Patients will be randomized (1:1) to one of two blood pressure management groups: a standard care group (targeting mean arterial pressure >65 mmHg or within 20% of baseline value), and a rScO₂-guided group (absolute value of rScO₂ >60% or decrease in rScO₂ <10% of baseline). The primary outcome is the composite outcome of major complications (including infectious, respiratory, neurologic, cardiovascular, renal, thromboembolic gastrointestinal, and surgical complications) and deaths within the first 7 days after surgery. Secondary outcomes include the individual components of the primary outcome by day 7 after surgery and 30-day mortality. Data will be analyzed in the modified intention-to-treat population.

Discussion: This study will provide evidence for improving postoperative outcomes using the rScO₂-guided blood pressure management among older adults who undergo major noncardiac surgery.

Trial registration: Chinese Clinical Trial Registry (Identifier: ChiCTR2200060816).

Keywords: blood pressure management; elderly patients; major noncardiac surgery; postoperative major complications; regional cerebral oxygen saturation.

Plain language summary

This is a protocol for a prospective, randomized, controlled clinical trial to evaluate the use of intraoperative individualized regional cerebral oxygen saturation (rScO₂) optimization for blood pressure management in older adults undergoing major noncardiac surgery. The primary focus of this trial is the composite outcome of major complications (including infectious, respiratory, neurologic, cardiovascular, renal, thromboembolic gastrointestinal, and surgical complications) and deaths within the first 7 days after surgery. The secondary outcomes are the individual components of the primary outcome by day 7 after surgery and 30-day mortality. The findings of this trial will provide clinical evidence for the rScO₂-guided blood pressure management to improve postoperative outcomes in older patients who are scheduled for major noncardiac surgery.

Grants and funding

This work will be supported by Suzhou Youth Science and Technology Project (KJXW2021008 to YFY), Jiangsu Medical Association Anesthesia Research Project (SYH-32021-0036 (2021031) to KP), Suzhou Medical Health Science and Technology Innovation Project (SKY2022136 to KP), Natural Science Foundation of Jiangsu Province (BK20200195 to WWH), National Natural Science Foundation of China (82072130 to FHJ), Six Talent Peaks Project in Jiangsu Province (WSN-022 to FHJ), Key Medical Research Projects in Jiangsu Province (ZD2022021 to FHJ), Suzhou Clinical Medical Center for Anesthesiology (Szlcyxzxj202102 to FHJ).