Elder Surgery-Functional Recovery after Beta Blockade

老年手术-β阻断后的功能恢复

• 批准号: 7114865
• 负责人: JEFFREY H SILVERSTEIN
• 金额: $ 28.62万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7114865
• 关键词: analgesics; anesthesia; behavioral /social science research tag; beta antiadrenergic agent; cardiovascular function; clinical research; clinical trials; cognition disorders; combination chemotherapy; comorbidity; delirium; functional ability; human old age (65+); human subject; human therapy evaluation; intravenous administration; longitudinal human study; morphine; myocardial ischemia /hypoxia; outcomes research; pain; patient oriented research; personal log /diary; postoperative complications; postoperative state; quality of life; stomach surgery; troponin

DESCRIPTION (provided by applicant): The ultimate objective of this work is to understand the major determinants of postoperative outcomes and to develop therapeutic modalities and practice parameters that maximize the rate, magnitude and quality of postoperative functional recovery in elderly surgical patients. The immediate objective is to evaluate the impact of anesthetic-coupled intra-operative beta-blockade on long term functional recovery in elders undergoing elective major abdominal surgery. The proposed research is a five-year randomized partial open-label trial of approximately 1100 patients 65 years of age or older having elective major abdominal surgery. Eligible patients will be divided into two groups: those currently receiving chronic beta-blockade or possessing risk factors for myocardial ischemia will be assigned to receive beta-blockers before and after surgery, those without risk factors will not. Within each group, eligible patients will be randomized to receive either a control anesthetic or anesthetic-coupled intra-operative beta-blockade. Patients will be evaluated preoperatively and postoperatively using a broad battery of functional and performance measures. Postoperative evaluations will take place over three stages: Stage 1 - end of surgery to discharge from the Post-Anesthesia Care Unit; Stage 2 - end of PACU stay through postoperative day three; and Stage 3 - postoperatively at one, three, and six weeks and three and six months. The impact of the intra-operative intervention will be assessed by pursuing the following specific aims: 1) comparison of the time course and extent of long-term (stage 3) functional recovery in elderly surgical patients receiving either a control or an anesthetic-coupled beta-blockade regimen; 2) comparison of the course of early (stage 1 and 2) recovery with particular reference to postoperative pain and analgesic medications in elderly surgical patients receiving either a control or an anesthetic-coupled beta-blockade regimen, and; 3) evaluation of the correlation between cardiac troponin release and cardiovascular outcome for six months following operation in elderly surgical patients receiving either a control or an anesthetic-coupled beta-blockade regimen. Primary outcomes measures will include: 1) Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) (Stage 3 recovery); 2) time to discharge from the Post Anesthesia Care Unit; 3) analgesic requirements self-reported pain by visual analogue scale; 4) incidence of delirium (confusion Assessment Method) (Stage 2 recovery); and 5) troponin I levels (Stage 1 and 2 recovery). The proposed trial leverages recent new data on the natural history of postoperative functional recovery in elders after abdominal surgery with pilot data suggesting that beta-blockade have beneficial effects on functional recovery to support the conduct of a randomized trial of an anesthetic intervention designed to improve short and long-term functional recovery in elders.

描述（由申请人提供）：这项工作的最终目标是了解术后结局的主要决定因素，并开发治疗方式和实践参数，以最大程度地提高老年人手术患者的术后功能恢复的速度，幅度和质量。直接目的是评估麻醉偶联的术中β-阻滞对长期功能恢复的影响，对经过选择性大腹部手术的长期恢复。拟议的研究是一项为期五年的随机部分开放标签试验，对大约1100名65岁或以上的患者进行了选择性的腹部手术。符合条件的患者将分为两组：那些目前接受慢性β受体阻滞或具有心肌缺血风险因素的患者将被分配在手术前和手术后接受β受体阻滞剂，而那些没有危险因素的患者不会。在每组中，符合条件的患者将被随机分配，以接受对照麻醉或麻醉偶联的术中β受体阻滞。将使用广泛的功能和绩效指标进行术前和术后评估患者。术后评估将在三个阶段进行：第1阶段 - 手术结束以从麻醉后护理单位出院；第2阶段 - PACU的结束至术后第三天；第三阶段 - 术后在一个，三个和六周，三个星期和六个月。术中干预措施的影响将通过追求以下特定目的来评估： 1）比较接受对照或麻醉偶联β-阻滞疗法的老年人外科手术患者的长期（第3阶段）功能恢复的比较； 2）比较早期（第1阶段和第2阶段）的恢复过程，特别是在接受对照或麻醉偶联的β-阻滞方案的老年人外科患者中术后疼痛和镇痛药的比较； 3）在手术后六个月内，接受对照或麻醉偶联的β-阻滞剂治疗的老年人手术患者的六个月后，心脏肌钙蛋白释放与心血管结局之间的相关性评估。 主要成果措施将包括：1）日常生活（ADL）的活动（ADL）和日常生活（IADL）（第3阶段恢复）； 2）从麻醉后护理单位出院的时间； 3）通过视觉模拟量表自我报告的止痛疼痛； 4）ir妄的发生率（混乱评估方法）（第2阶段恢复）； 5）肌钙蛋白I水平（第1阶段和第2阶段恢复）。 拟议的试验利用了有关腹部手术后长辈术后功能恢复自然史的最新新数据，并用试验数据表明，β受体阻滞对功能恢复具有有益的作用，以支持进行麻醉干预的随机试验，旨在改善短暂的速度和长期的长期功能恢复。