Li Tianchun, Zang Han, Che Lu, Cui Quexuan, Xu Li
Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.
BMJ Open. 2025 May 30;15(5):e095466. doi: 10.1136/bmjopen-2024-095466.
Post-induction hypotension (PIH) is particularly common in elderly patients undergoing general anaesthesia and is associated with severe postoperative complications. Autonomic nervous system (ANS) dysfunction is a potential risk factor for significant haemodynamic fluctuations during general anaesthesia in elderly patients. Tools to identify ANS are currently lacking in perioperative clinical practice. Postprandial hypotension (PPH) is closely linked to ANS dysfunction and is also common among elderly individuals. Therefore, this study aims to explore the relationship between PPH and PIH in elderly patients undergoing non-cardiac surgery. By examining this correlation, we hope to better understand the factors contributing to PIH and explore the potential role of PPH in predicting PIH.
This is a prospective observational cohort study. 120 elderly Chinese patients aged ≥65 years and scheduled to undergo non-cardiac surgery under general anaesthesia at Peking Union Medical College Hospital (PUMCH) will be included. PPH assessments will include baseline pre-prandial records and blood pressure measurements immediately after meal completion, followed by every 5 min for 120 min. To evaluate PIH, blood pressure will be monitored from the patients' entry into the operating room until 20 min after anaesthesia induction or the initiation of surgery. PIH is defined as systolic blood pressure of <90 mmHg or main arterial pressure <65 mmHg or a decrease of more than 30% from baseline within 20 min after general anaesthesia induction or before surgical incision. Baseline assessment will include regular preoperative assessment, symptoms and medical history related to baroreflex dysfunction, and preoperative volume status will be assessed by passive leg raising test. Follow-up will be conducted at 1, 3, 7 and 30 days and 6 months postoperatively. The primary outcome is PIH. Secondary outcomes include early intraoperative hypotension, postoperative complications graded by Clavien-Dindo classification, 30-day postoperative mortality and 12-item WHO Disability Assessment Schedule 2.0 (12-item WHODAS 2.0) score 6 months postoperatively.
This study has been registered in the ClinicalTrials.gov system of the National Institutes of Health (registration number NCT05575661). The Ethics Committee of PUMCH has also granted ethical approval (approval number I-22PJ008). The study results will be disseminated through publication in peer-reviewed journals focused on anaesthesiology and geriatric medicine, as well as presentations at relevant scientific conferences.
NCT05575661.
诱导后低血压（PIH）在接受全身麻醉的老年患者中尤为常见，并与严重的术后并发症相关。自主神经系统（ANS）功能障碍是老年患者全身麻醉期间出现显著血流动力学波动的潜在危险因素。围手术期临床实践中目前缺乏识别ANS的工具。餐后低血压（PPH）与ANS功能障碍密切相关，在老年人中也很常见。因此，本研究旨在探讨接受非心脏手术的老年患者中PPH与PIH之间的关系。通过研究这种相关性，我们希望更好地了解导致PIH的因素，并探讨PPH在预测PIH方面的潜在作用。
这是一项前瞻性观察性队列研究。将纳入120例年龄≥65岁、计划在北京协和医院（PUMCH）接受全身麻醉下非心脏手术的中国老年患者。PPH评估将包括餐前基线记录和餐后立即测量血压，随后每5分钟测量一次，共120分钟。为评估PIH，将在患者进入手术室后直至麻醉诱导后20分钟或手术开始时监测血压。PIH定义为全身麻醉诱导后或手术切口前20分钟内收缩压<90 mmHg或平均动脉压<65 mmHg或较基线下降超过30%。基线评估将包括常规术前评估、与压力反射功能障碍相关的症状和病史，术前容量状态将通过被动抬腿试验进行评估。术后1、3、7和30天以及6个月进行随访。主要结局是PIH。次要结局包括术中早期低血压、根据Clavien-Dindo分类法分级的术后并发症、术后30天死亡率以及术后6个月的世界卫生组织残疾评定量表2.0（12项WHODAS 2.0）评分。
本研究已在美国国立卫生研究院的ClinicalTrials.gov系统注册（注册号NCT05575661）。北京协和医院伦理委员会也已批准（批准号I-22PJ008）。研究结果将通过发表在专注于麻醉学和老年医学的同行评审期刊上以及在相关科学会议上进行报告来传播。
NCT05575661。
