Moppett Iain Keith, White Stuart, Griffiths Richard, Buggy Donal
Anaesthesia and Critical Care Section, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Department of Anaesthesia, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.
Trials. 2017 Jul 25;18(1):350. doi: 10.1186/s13063-017-2066-5.
Hypotension during anaesthesia for hip fracture surgery is common. Recent data suggest that there is an association between the lowest intra-operative blood pressure and mortality, even when adjusted for co-morbidities. This is consistent with data derived from the wider surgical population, where magnitude and duration of hypotension are associated with mortality and peri-operative complications. However, there are no trial to data to support more aggressive blood pressure control.
METHODS/DESIGN: We are conducting a three-centre, randomised, double-blinded pilot study in three hospitals in the United Kingdom. The sample size will be 75 patients (25 from each centre). Randomisation will be done using computer-generated concealed tables. Both participants and investigators will be blinded to group allocation. Participants will be aged >70 years, cognitively intact (Abbreviated Mental Test Score 7 or greater), able to give informed consent and admitted directly through the emergency department with a fractured neck of the femur requiring operative repair. Patients randomised to tight blood pressure control or avoidance of intra-operative hypotension will receive active treatment as required to maintain both of the following: systolic arterial blood pressure >80% of baseline pre-operative value and mean arterial pressure >75 mmHg throughout. All participants will receive standard hospital care, including spinal or general anaesthesia, at the discretion of the clinical team. The primary outcome is a composite of the presence or absence of defined cardiovascular, renal and delirium morbidity within 7 days of surgery (myocardial injury, stroke, acute kidney injury, delirium). Secondary endpoints will include the defined individual morbidities, mortality, early mobility and discharge to usual residence.
This is a small-scale pilot study investigating the feasibility of a trial of tight intra-operative blood pressure control in a frail elderly patient group with known high morbidity and mortality. Positive findings will provide the basis for a larger-scale study.
ISRCTN Registry identifier: ISRCTN89812075 . Registered on 30 August 2016.
髋部骨折手术麻醉期间低血压很常见。近期数据表明，即使对合并症进行了调整，术中最低血压与死亡率之间仍存在关联。这与更广泛的外科手术人群的数据一致，在该人群中，低血压的程度和持续时间与死亡率及围手术期并发症相关。然而，目前尚无试验数据支持更积极的血压控制。
方法/设计：我们正在英国的三家医院开展一项三中心、随机、双盲的试点研究。样本量为75例患者（每个中心25例）。随机分组将使用计算机生成的隐藏表格进行。参与者和研究者都将对分组情况不知情。参与者年龄>70岁，认知功能完整（简易精神状态检查表评分7分或更高），能够给予知情同意，且因股骨颈骨折需要手术修复而直接通过急诊科入院。随机分配到严格血压控制组或避免术中低血压组的患者将根据需要接受积极治疗，以维持以下两项指标：收缩动脉血压>术前基线值的80%，且整个过程平均动脉压>75 mmHg。所有参与者将根据临床团队的判断接受标准的医院护理，包括脊髓麻醉或全身麻醉。主要结局是术后7天内是否存在特定的心血管、肾脏和谵妄相关并发症（心肌损伤、中风、急性肾损伤、谵妄）的综合情况。次要终点将包括特定的个体并发症、死亡率、早期活动能力以及出院后返回常住地的情况。
这是一项小规模的试点研究，旨在调查在已知发病率和死亡率较高的体弱老年患者群体中进行术中严格血压控制试验的可行性。阳性结果将为大规模研究提供基础。
国际标准随机对照试验编号：ISRCTN89812075。于2016年8月30日注册。
