Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine nasal spray.
- Who it may be relevant to
- Registry conditions: Postoperative Delirium, Preoperative Sleep Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients：a Single-center, Double- Blind, Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Drug 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.
Primary outcome measures
- Postoperative delirium occurrence [Time frame: within 1 week after operation]
Secondary outcome measures (8)
- Delirium severity measurement [Time frame: 1week after surgery]
- Delirium subtypes [Time frame: 1week after surgery]
- Duration of delirium [Time frame: 1week after surgery]
- Hospital length of stay. [Time frame: From the date of surgery until the date patient discharge from hospital, assessed up to 30 days]]
- In- hospital mortality [Time frame: 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 [Time frame: The first night after surgery]
- Postoperative anxiety and depression [Time frame: 1week after surgery]
- Pain intensity [Time frame: 1week after surgery]
Eligibility criteria
Inclusion criteria
- Aged 18 years or older.
- Cardiac surgery with cardiopulmonary bypass.
- Ability to provide consent.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Xijing Hospital — Xi'an
Publications
- 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
Identifiers
NCT: NCT06619912 · KY20242259