背景:生命末期的镇静用于缓解包括躁动和谵妄在内的痛苦症状。标准护理可包括输注苯二氮卓类药物或抗精神病药。这些药物通常会导致深度镇静,失去与亲人的互动,这可能是令人沮丧的。
目的:DREAMS(右美托咪定用于减少生命末期激动和优化镇静)试验旨在比较α-2激动剂右美托咪定的镇静和抗谵妄作用,一种新颖的姑息治疗镇静剂,与咪达唑仑相比,在生命结束时通过皮下输注给予苯二氮卓类药物,两种药物的剂量都是针对较轻的,或潜在的交互式镇静剂。
方法:参与者从新南威尔士州地区姑息治疗小组下接受临终关怀的成年住院患者中招募,澳大利亚。纳入标准包括18岁以上的患者,在生命结束时偏爱较轻的镇静剂。排除标准包括严重心功能不全(右美托咪定禁忌症)。参与者同意并被列入待定治疗名单。在经历终端恶化时,患者被随机分为第1组(右美托咪定)或第2组(咪达唑仑)作为治疗组.通过连续皮下输注施用这些治疗。通过里士满激动镇静量表-姑息版和纪念谵妄评估评分来测量患者的意识和躁动水平。里士满激动-镇静量表-姑息性评估由护理人员和医务人员进行,而纪念谵妄评估评分仅由医务人员进行。家属和患者被要求完成,作为能够,患者舒适度评估表,来衡量对痛苦的看法。收集数据并与所给予的突破性药物剂量相匹配,以及病历中的定性评论。此外,该研究追踪了作为姑息治疗结果一部分记录的症状和患者功能状态,监测姑息治疗中症状结局的国家跟踪项目.
结果:DREAMS试验于2020年5月获得资助,并于2020年11月获得伦理委员会的批准,并于2021年5月开始招募参与者。数据收集于2021年5月开始,预计将持续到2024年12月。预计将于2024年至2026年公布结果。
结论:姑息治疗中镇静剂给药的证据并不可靠,标准护理主要基于临床经验,而不是强有力的科学证据。这项研究很重要,因为它将比较用于临终治疗的标准镇静剂和新型镇静剂。通过评估两者的潜在疗效和益处,它旨在通过提供有针对性的镇静剂来优化死亡质量,从而改善垂死患者与亲人之间的沟通。
背景:澳大利亚新西兰临床试验注册ACTRN12621000052831;https://uat。anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380889。
■DERR1-10.2196/55129。
BACKGROUND: Sedation at the end of life is used to relieve distressing symptoms including agitation and delirium. Standard care may include infused benzodiazepines or antipsychotics. These agents often result in deep
sedation with loss of interaction with loved ones, which may be distressing.
OBJECTIVE: The DREAMS (Dexmedetomidine for the Reduction of End-of-life Agitation and for optiMised
Sedation) trial aimed to compare the sedative and antidelirium effects of the alpha-2 agonist dexmedetomidine, a novel palliative care sedative, compared with midazolam, a benzodiazepine when administered by subcutaneous infusion at the end of life, with doses of both agents targeting lighter, or potentially interactive sedation.
METHODS: Participants were recruited from adult inpatients admitted for end-of-life care under a palliative care team in regional New South Wales, Australia. Inclusion criteria included patients older than 18 years, with a preference for lighter
sedation at the end of life. Exclusion criteria included severe cardiac dysfunction (contraindication to dexmedetomidine). Participants consented and were placed on a treatment-pending list. Upon experiencing terminal deterioration, patients were randomized to either arm 1 (dexmedetomidine) or arm 2 (midazolam) as their treatment arm. These treatments were administered by continuous subcutaneous infusion. The level of consciousness and agitation of the patients were measured by the Richmond Agitation-
Sedation Scale-Palliative version and the Memorial Delirium Assessment Score. Richmond Agitation-Sedation Scale-Palliative version assessments were performed by both nursing and medical staff, while Memorial Delirium Assessment Score assessments were carried out by medical staff only. Families and patients were asked to complete, as able, a patient comfort assessment form, to gauge perceptions of distress. Data were collected and matched with the breakthrough medication doses administered, along with qualitative comments in the medical record. In addition, the study tracked symptoms and patient functional status that were recorded as part of the Palliative Care Outcomes Collaborative, a national tracking project for monitoring symptom outcomes in palliative care.
RESULTS: The DREAMS trial was funded in May 2020, approved by the ethics committee in November 2020, and started recruiting participants in May 2021. Data collection commenced in May 2021 and is anticipated to continue until December 2024. Publication of results is anticipated from 2024 to 2026.
CONCLUSIONS: The evidence base for sedative dosing in palliative care for distress and agitation is not robust, with standard care based primarily on clinical experience and not robust scientific evidence. This study is important because it will compare a standard and a novel sedative used in end-of-life treatment. By assessing the potential efficacy and benefits of both, it seeks to optimize the quality of dying by providing targeted sedation that can improve the communication between dying patients and their loved ones.
BACKGROUND: Australia New Zealand Clinical Trials Register ACTRN12621000052831; https://uat.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380889.
UNASSIGNED: DERR1-10.2196/55129.