Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients

Официальное название

Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients：a Single-center, Double- Blind, Controlled Trial

Обзор

Delirium is a common consequence of cardiac surgery and associates with poor outcomes. Multiple causes can trigger delirium occurence, and it has been hypothesised that sleep disturbances can be one of them. Dexmedetomidine may be effective in reducing delirium. The aim of this study was to demonstrate preoperative dexmedetomidine nasal spray in cardiac surgery patients can reduce postoperative delirium by improving preoperative sleep.

Подробное описание

Due to special reasons such as surgical trauma, irritability, extracorporeal circulation, the incidence of postoperative delirium (POD) after cardiovascular surgery ranges from 26% to 52%. POD is an acute organic brain syndrome characterised by cognitive impairment and alteration of consciousness. The implications of this acute form of brain injury are profound. Patients who experience delirium are more likely to experience increased short- and long-term mortality, decrease in long-term cognitive function, increase in hospital length of stay and increased complications of hospital care. Given the numerous adverse effects of POD, it is crucial to explore the mechanisms for the prevention and management of POD.

Dexmedetomidine (Dex) is a highly selective α 2-adrenergic receptor agonist that produces sedative and hypnotic effects by activating the α 2-adrenergic receptor in the brainstem locus coeruleus, and has a certain neuroprotective effect. In recent years, the prevention of postoperative delirium by Dex has been a hot topic in the field of anesthesia. However, recent studies have found contradictory conclusions on aforementioned topic.

The heterogeneity of the subject population may be the reason for the current contradictory conclusions. Tang et al. conducted a meta-analysis of all RCTs regarding perioperative sleep interventions and postoperative delirium, and found that in the subgroup where interventions effectively improved patients' sleep quality, the effect of reducing the incidence of postoperative delirium was more significant. At the same time, the incidence of delirium did not decrease in the subgroup where sleep quality was not improved. Sleep disorders play a crucial role in the pathogenesis of POD.

In this DREAMS study, we plan to conduct a single center double-blind randomized controlled trial involving patients undergoing extracorporeal circulation cardiac surgery to explore whether administering Dex nasal spray the night before surgery and 30 minutes before anesthesia induction can improve preoperative sleep quality and reduce the incidence of postoperative delirium.

Вмешательства

• Препарат Dexmedetomidine nasal spray
  Participants will be randomised to receive either dexmedetomidine or saline nasal spray (1.5ug/kg, ideal body weight) at the night before surgery and 30 minutes before induction.

Первичные конечные точки

• Postoperative delirium occurrence [Срок оценки: within 1 week after operation]

Вторичные конечные точки (8)

• Delirium severity measurement [Срок оценки: 1week after surgery]
• Delirium subtypes [Срок оценки: 1week after surgery]
• Duration of delirium [Срок оценки: 1week after surgery]
• Hospital length of stay. [Срок оценки: From the date of surgery until the date patient discharge from hospital, assessed up to 30 days]]
• In- hospital mortality [Срок оценки: From the date of surgery until the date patient discharge from hospital, assessed up to 30 days]]
• NRS score of sleep during the first night after surgery [Срок оценки: The first night after surgery]
• Postoperative anxiety and depression [Срок оценки: 1week after surgery]
• Pain intensity [Срок оценки: 1week after surgery]

Критерии участия

Критерии включения

• Aged 18 years or older.
• Cardiac surgery with cardiopulmonary bypass.
• Ability to provide consent.

Критерии исключения

• Preoperative schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, history of neurosurgery, or Mini-mental State Examination(MMSE) score: illiteracy<17, primary school level<20, high school level <24.
• Patients with sick sinus syndrome, severe sinus bradycardia (heart rate<50 beats/minute), grade II or above atrioventricular block, and no pacemaker implanted.
• Unable to communicate due to coma, severe dementia, or language barriers prior to surgery.
• Patients with severe liver dysfunction (Child Pugh C grade), renal dysfunction (preoperative dialysis), ASA grade V or expected survival ≤ 24 hours.
• Heart transplant surgery
• Surgery for congenital heart disease.
• Deep hypothermic circulatory arrest surgery.
• Already enrolled in other study patients.
• Refuse to participate.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Xijing Hospital — Сиань

Публикации

• Wu M, Liang Y, Dai Z, Wang S. Perioperative dexmedetomidine reduces delirium after cardiac surgery: A meta-analysis of randomized controlled trials. J Clin Anesth. 2018 Nov;50:33-42. doi: 10.1016/j.jclinane.2018.06.045. Epub 2018 Jun 27. PMID 29958125
• Turan A, Duncan A, Leung S, Karimi N, Fang J, Mao G, Hargrave J, Gillinov M, Trombetta C, Ayad S, Hassan M, Feider A, Howard-Quijano K, Ruetzler K, Sessler DI; DECADE Study Group. Dexmedetomidine for reduction of atrial fibrillation and delirium after cardiac surgery (DECADE): a randomised placebo-controlled trial. Lancet. 2020 Jul 18;396(10245):177-185. doi: 10.1016/S0140-6736(20)30631-0. PMID 32682483
• Zhang Z, Yang X, Qin Y, Gao B, Wang Y, Ji J, Gao J, Huang M, Wang L, Zheng Z, Lei C. Intranasal dexmedetomidine in reducing postoperative delirium among cardiac surgery patients by improving sleep quality in China (DREAMS): study protocol for a single-centre, double-blind, randomised controlled trial. BMJ Open. 2026 Apr 21;16(4):e110057. doi: 10.1136/bmjopen-2025-110057. PMID 42014143

Идентификаторы

NCT: NCT06619912 · KY20242259

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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