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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental | The Dexmedetomidine group will receive dexmedetomidine nasal spray (1.5ug/kg, ideal body weight) at the night before surgery and 30 minutes before induction. |
|
| Control group | No Intervention | In the control group, the treatment is sodium chloride 0.9% nasal spray. Follows the same rules as in the experimental group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine nasal spray | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative delirium occurrence | Delirium occurrence was evaluated with confusion assessment method for the ICU(CAM- ICU) or 3-Minute Confusion Assessment Method (3D-CAM) two times per day during the 7 days following surgery. | within 1 week after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium severity measurement | Delirium severity is assessed using Confusion Assessment Method for the intensive care unit (CAM-ICU)-7, score 3-5 is considered as mild to moderate delirium, score 6-7 is considered as severe delirium | 1week after surgery |
| Delirium subtypes |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative occurence of AKI | AKI occurrence was evaluated with KIDGO guideline during the 7 days following surgery. | 1week after surgery |
| Plasma concentration of pTau-217 | Preoperative plasma pTau-217 level is detected after the second dose of the test drug is conducted, and the postoperative plasma pTau-217 level is detected 24 hours after surgery. Plasma pTau-217 level is determined using the Quanterix method that is based on ultrasensitive Simoa technology,on an HD-X analytical platform. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chong Lei, M.D., phd | Contact | 86-18629011362 | crystalleichong@126.com | |
| Zefei Zhang, M.D. | Contact | 86-18811797795 | zzfanita7@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chong Lei, M.D., phd | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29958125 | Background | 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. | |
| 32682483 | Background | 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. |
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Individual participant data that underline the results reported in this article, after deidentification.
beginning 12 months
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Hyperactive POD was defined as a RASS score of +1 to +4 accompanying a positive CAM-ICU/3D-CAM, hypoactive POD was defined as a RASS score of -3 to 0 accompanying a positive CAM-ICU/3D-CAM, mixed POD was defined by simultaneous or sequential exhibition of hypoactive and hyperactive manifestationscare unit (CAM-ICU)-7, score 3-5 is considered as mild to moderate delirium, score 6-7 is considered as severe delirium |
| 1week after surgery |
| Duration of delirium | Duration of delirium is assessed using Confusion Assessment Method for the intensive care unit (CAM-ICU) or 3-Minute Confusion Assessment Method (3D-CAM) | 1week after surgery |
| Hospital length of stay. | Hospital length of stay. | From the date of surgery until the date patient discharge from hospital, assessed up to 30 days] |
| In- hospital mortality | In- hospital mortality | 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 | NRS score of sleep during the first night after surgery | The first night after surgery |
| Postoperative anxiety and depression | Postoperative anxiety and depression are assessed using Hospital Anxiety and Depression Scale (HADS) | 1week after surgery |
| Pain intensity | 1) Pain intensity is assessed using the NRS at rest and during movement daily for 7 postoperative days | 1week after surgery |
| 24h after surgery |
| Postoperative occurence of atrial fibrillation | Postoperative occurence of atrial fibrillation | 1week after surgery |
| 42014143 | Derived | 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. |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |