METHODS OF ANESTHESIA AND ANALGESIA FOR AORTIC SURGERY

主动脉手术的麻醉和镇痛方法

• 批准号: 2179190
• 负责人: RICHARD J TRAYSTMAN
• 金额: $ 31.65万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1988
• 资助国家: 美国
• 起止时间: 1988-04-01 至 1996-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2179190
• 关键词: analgesia; anesthesia complication; aorta; blood chemistry; cardiovascular surgery; clinical trials; electrocardiographic monitor; epidural anesthesia; general anesthesia; health care cost /financing; health care quality; human mortality; human subject; isozymes; longitudinal human study; patient care management; postoperative complications; questionnaires; stress

This investigation is designed to assess the impact of alternate combinations of intraoperative anesthesia and postoperative analgesia on the human stress response, selected morbidities, and the cost of medical care for patients undergoing major vascular surgery. Improvement in patient outcome and reduced utilization of medical resources have been suggested to result from using regional anesthetic techniques as compared to general anesthesia alone for large operative procedures. Studies that report this finding have suffered from methodologic problems including the use of non-equivalent modalities for postoperative pain relief and the failure to assure optimized clinical care in both groups. It remains unknown whether the benefits discovered are due to specific features of either the intraoperative or the postoperative technique, or to unrevealed aspects of patient management. To clearly separate the influence of time period and technique, remove physician bias, and provide comparable care in all groups we propose a five-year double blind clinical trial of 240 patients undergoing surgery of the abdominal aorta. Subjects will be randomized to one of four groups to receive either regional supplemented general anesthesia or general anesthesia alone during surgery, and either intravenous or epidural patient controlled analgesia after surgery. Specific aims of the study are to compare, between the four groups: 1) indices of the human stress response, 2) mortality and morbidity, and 3) return to physiologic independence and cost of medical care. All aspects of perioperative medical management will be specified by protocol. Data collection will include: 96 hours of continuous Holter monitoring; serial EKG's, and physical examinations; serial blood samples for cardiac isoenzymes, norepinephrine, epinephrine; urinary cortisols; vital sign analysis; discharge chart review and three and six month follow-up. Unique features of this proposal are the standardization of clinical care throughout the perioperative period, inclusion of all four combinations of intraoperative anesthesia and postoperative analgesia, patient and treating physicians blinded, and evaluation of the stress response. We hope to resolve issues of importance to both the quality and the cost of medical care and contribute to the understanding of physiologic factors which underlie perioperative morbidity. A finding of significant differences between groups will allow clinicians to adopt methods with due regard for both safety and economy while a finding of no difference will allow choice based on preference.

本调查旨在评估替代方案的影响 术中麻醉和术后镇痛的联合应用， 人类的应激反应，选定的发病率，以及医疗费用 护理接受大血管手术的患者。 改善患者结局，减少医疗使用 已经有人建议使用区域麻醉剂 与单纯全身麻醉相比， 程序. 报告这一发现的研究受到了 方法学问题，包括使用非等效模式， 术后疼痛缓解和未能确保优化的临床 两组的护理。 目前尚不清楚所发现的益处是否 是由于术中或术中的特定特征， 术后技术，或患者管理的未公开方面。 为了清楚地区分时间段和技术的影响， 医生偏见，并提供可比的照顾，在所有群体中，我们提出了一个 240例手术患者的5年双盲临床试验 腹主动脉的一部分 受试者将被随机分配至以下四组之一： 接受区域补充全身麻醉或 在手术过程中单独全身麻醉，静脉内或 术后硬膜外自控镇痛。 具体目标 本研究比较了四组之间的：1） 人类应激反应，2）死亡率和发病率，以及3）返回 生理独立性和医疗费用。 围手术期医疗管理的所有方面将由 议定书 数据收集将包括：96小时连续霍尔特 监测;系列心电图和体格检查;系列血液样本 心脏同工酶，去甲肾上腺素，肾上腺素;尿皮质醇; 生命体征分析;出院病历审查和3个月和6个月 随访 该提案的独特之处在于， 整个围手术期的临床护理，包括所有四个 术中麻醉和术后镇痛的组合， 患者和治疗医生设盲，并评估压力 反应 我们希望解决质量和成本方面的重要问题 医疗保健，并有助于了解生理 围手术期发病率的基础因素。 一项重大发现 组间差异将允许临床医生采用 适当考虑安全性和经济性， 将允许基于偏好的选择。