PREVENTION OF CEREBRAL DYSFUNCTION DURING OPEN HEART SURGERY

心脏直视手术期间预防脑功能障碍

• 批准号: 3766671
• 负责人: LAVERNE GUGINO
• 金额: --
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3766671
• 关键词: central nervous system disorders; chemoprevention; clinical trials; dosage; heart /lung bypass; human subject; human therapy evaluation; medical complication; neuroprotectants; postoperative state

This protocol describes a study designed to test the hypothesis that treatment with OPC-14117 ( a neuroprotective agent and cognitive enhancer) prevents central nervous system dysfunction following cardiopulmonary bypass surgery. Three groups of 21 subjects will be studied; one group on placebo, a second on 60mg/day and a third on 120 mg/day of OPC-14117. The study will be conducted as a randomized, double blind, placebo-controlled design. QEEG data will be collected one week prior to and during surgery.

本方案描述了一项旨在检验以下假设的研究， 用OPC-14117（一种神经保护剂和认知调节剂）治疗 增强剂）预防中枢神经系统功能障碍， 体外循环手术 三组21名受试者将被 研究;一组安慰剂，第二组60毫克/天，第三组120毫克/天 mg/天的OPC-14117。 本研究将以随机化、双盲 盲法、安慰剂对照设计。将在一周内收集QEEG数据 手术前和手术中