Xijing Hospital
Xi'an, Shaanxi, 710032, China
Location status: Recruiting
NCT Number: NCT06619912
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Xi'an, Shaanxi, 710032, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: within 1 week after operation
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.
Time frame: 1week after surgery
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
Time frame: 1week after surgery
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
Time frame: 1week after surgery
Duration of delirium is assessed using Confusion Assessment Method for the intensive care unit (CAM-ICU) or 3-Minute Confusion Assessment Method (3D-CAM)
Time frame: From the date of surgery until the date patient discharge from hospital, assessed up to 30 days]
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: The first night after surgery
NRS score of sleep during the first night after surgery
Time frame: 1week after surgery
Postoperative anxiety and depression are assessed using Hospital Anxiety and Depression Scale (HADS)
Time frame: 1week after surgery
Time frame: 1week after surgery
AKI occurrence was evaluated with KIDGO guideline during the 7 days following surgery.
Time frame: 24h after surgery
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.
Time frame: 1week after surgery
Postoperative occurence of atrial fibrillation
Contact information is provided by the study sponsor or research team.
Chong Lei, M.D., phd
CONTACT
Zefei Zhang, M.D.
CONTACT
Xijing Hospital
Other
Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients:a Single-center, Double- Blind, Controlled Trial
Acronym: DREAMS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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