Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619912
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Dexmedetomidine in Reducing Postoperative Delirium Among Cardiac Surgery Patients With Preoperative Sleep Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dexmedetomidine in Reducing Postoperative Delirium Among Cardiac Surgery Patients With Preoperative Sleep Disorders a Single-center Double- Blind Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 infusion may be effective in reducing delirium The aim of this study was to demonstrate long-term use of low-dose dexmedetomidine in cardiac surgery patients with preoperative sleep disorders PSD can reduce delirium by improving sleep efficiency
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
Recent research indicates that sleep disorder plays a crucial role in the pathogenesis of POD Preoperative sleep disorderPSD is common in surgical patients up to 40 of hospitalized patients undergoing major surgeries are affected by it Grimaldi et al found that sleep disorder results changes in plasma cortisol and norepinephrine which further revealing that changes in sleep microstructure in elderly patients are related to autonomic dysfunction Mechanisticly sleep disorder is a physiological stressor resulting in an allostatic load contributing to cognitive problems and delirium
Given a growing number of studies have proved the significant association between sleep disorders and delirium it is therefore not surprising that optimized sleep can reduce delirium Dexmedetomidine has shown good efficacy in the treatment of sleep disorders improving the sleep structure of elderly patients and ameliorating their subjective sleep quality However conclusions varies on the prevention effect of dexmedetomidine on POD Some researches confirmed the prevention effect of dexmedetomidine but DECADE DEXACET DIRECT had contrary conclusion The variations in population could be the reason of the phenomenon Tang et al conducted a meta-analysis with all randomized controlled trials RCTs of perioperative sleep interventions and POD enrolled they found that in the subgroup where interventions effectively improved sleep quality the effect of reducing POD was more significant
Therefore the investigators speculate that long-term use of low-dose Dexmedetomidine in cardiac surgery patients with preoperative sleep disorders can reduce the occurrence of POD by improving sleep efficiency
Recent research indicates that sleep disorder plays a crucial role in the pathogenesis of POD Preoperative sleep disorderPSD is common in surgical patients up to 40 of hospitalized patients undergoing major surgeries are affected by it Grimaldi et al found that sleep disorder results changes in plasma cortisol and norepinephrine which further revealing that changes in sleep microstructure in elderly patients are related to autonomic dysfunction Mechanisticly sleep disorder is a physiological stressor resulting in an allostatic load contributing to cognitive problems and delirium
Given a growing number of studies have proved the significant association between sleep disorders and delirium it is therefore not surprising that optimized sleep can reduce delirium Dexmedetomidine has shown good efficacy in the treatment of sleep disorders improving the sleep structure of elderly patients and ameliorating their subjective sleep quality However conclusions varies on the prevention effect of dexmedetomidine on POD Some researches confirmed the prevention effect of dexmedetomidine but DECADE DEXACET DIRECT had contrary conclusion The variations in population could be the reason of the phenomenon Tang et al conducted a meta-analysis with all randomized controlled trials RCTs of perioperative sleep interventions and POD enrolled they found that in the subgroup where interventions effectively improved sleep quality the effect of reducing POD was more significant
Therefore the investigators speculate that long-term use of low-dose Dexmedetomidine in cardiac surgery patients with preoperative sleep disorders can reduce the occurrence of POD by improving sleep efficiency
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None