Minimizing ICU Neurological Dysfunction with Dexmedetomidine-induced Sleep (MINDDS): protocol for a randomised, double-blind, parallel-arm, placebo-controlled trial.
Minimizing ICU Neurological Dysfunction with Dexmedetomidine-induced Sleep (MINDDS): protocol for a randomised, double-blind, parallel-arm, placebo-controlled trial.
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DOI：
10.1136/bmjopen-2017-020316
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发表时间：
2018-04-20
期刊：
影响因子：
2.9
通讯作者：
Akeju O
中科院分区：
文献类型：
--
作者：
Shelton KT;Qu J;Bilotta F;Brown EN;Cudemus G;D'Alessandro DA;Deng H;DiBiasio A;Gitlin JA;Hahm EY;Hobbs LE;Houle TT;Ibala R;Loggia ML;Pavone KJ;Shaefi S;Tolis G;Westover MB;Akeju O
妄想症在心脏手术后患者中很常见，是一种急性脑功能障碍，其特征是注意力、意识和认知方面的障碍，而不是用先前存在的神经认知障碍来解释。精神错乱的病理生理学仍知之甚少。然而，基础科学和临床研究表明，睡眠障碍可能是导致精神错乱的一个可改变的危险因素。右美托咪定是一种α-2A肾上腺素能受体激动剂药物，类似于睡眠，它可以改变各种觉醒核团的活动。单次夜间负荷量的右美托咪定可促进非快速眼动睡眠阶段的N2和N3睡眠。这项试验假设右美托咪定诱导的睡眠是术后精神障碍的预防性治疗。MINDDS(用右美托咪定诱导睡眠最小化ICU神经功能障碍)试验是一项有370名患者参加的分组随机、安慰剂对照、双盲、单部位、平行臂优势试验。60岁以上的患者，在计划的体外循环下接受心脏手术，将被随机接受诱导睡眠剂量的右美托咪啶或安慰剂。主要的结果是术后第一天的神志不清的发生率，由对治疗任务视而不见的工作人员用迷惑评估法进行评估。为了确保这项研究为主要结果衡量提供适当的动力，将招募患者并随机进入研究，直到370名患者在术后第0天接受研究干预。将通过对住院终点的面对面评估和医疗记录审查，以及对30天、90天和180天终点的电话访谈来评估次要结果。所有试验结果将使用意向治疗分析计划进行评估。假设检验将使用α=0.05的双侧显著性水平(I类错误)来执行。将使用实际接受的治疗进行敏感性分析，并与意向治疗分析结果进行比较。额外的敏感性分析将评估由于失去后续行动而丢失数据的潜在影响。合作伙伴人类研究委员会批准了MINDDS试验。招聘工作于2017年3月开始。传播计划包括在科学会议、科学出版物和大众媒体上发表演讲。NCT02856594。
Delirium, which is prevalent in postcardiac surgical patients, is an acute brain dysfunction characterised by disturbances in attention, awareness and cognition not explained by a pre-existing neurocognitive disorder. The pathophysiology of delirium remains poorly understood. However, basic science and clinical studies suggest that sleep disturbance may be a modifiable risk factor for the development of delirium. Dexmedetomidine is a α-2A adrenergic receptor agonist medication that patterns the activity of various arousal nuclei similar to sleep. A single night-time loading dose of dexmedetomidine promotes non-rapid eye movement sleep stages N2 and N3 sleep. This trial hypothesises dexmedetomidine-induced sleep as pre-emptive therapy for postoperative delirium. The MINDDS (Minimizing ICU Neurological Dysfunction with Dexmedetomidine-induced Sleep) trial is a 370-patient block-randomised, placebo-controlled, double-blinded, single-site, parallel-arm superiority trial. Patients over 60 years old, undergoing cardiac surgery with planned cardiopulmonary bypass, will be randomised to receive a sleep-inducing dose of dexmedetomidine or placebo. The primary outcome is the incidence of delirium on postoperative day 1, assessed with the Confusion Assessment Method by staff blinded to the treatment assignment. To ensure that the study is appropriately powered for the primary outcome measure, patients will be recruited and randomised into the study until 370 patients receive the study intervention on postoperative day 0. Secondary outcomes will be evaluated by in-person assessments and medical record review for in-hospital end points, and by telephone interview for 30-day, 90-day and 180-day end points. All trial outcomes will be evaluated using an intention-to-treat analysis plan. Hypothesis testing will be performed using a two-sided significance level (type I error) of α=0.05. Sensitivity analyses using the actual treatment received will be performed and compared with the intention-to-treat analysis results. Additional sensitivity analyses will assess the potential impact of missing data due to loss of follow-up. The Partners Human Research Committee approved the MINDDS trial. Recruitment began in March 2017. Dissemination plans include presentations at scientific conferences, scientific publications and popular media. NCT02856594.
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影响因子：
3.9
作者：
Cunningham C
通讯作者：
Cunningham C
神经振荡表明全身麻醉和镇静状态在神经生理学上与睡眠不同。
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