Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

686 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-03

Study Completion Date

2027-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Delirium Preoperative Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexmedetomidine group

The Dexmedetomidine group will receive dexmedetomidine nasal spray （1.5ug/kg, ideal body weight) at the night before surgery and 30 minutes before induction.

Group Type EXPERIMENTAL

Dexmedetomidine nasal spray

Intervention Type 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.

Control group

In the control group, the treatment is sodium chloride 0.9% nasal spray. Follows the same rules as in the experimental group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Aged 18 years or older.
2. Cardiac surgery with cardiopulmonary bypass.
3. Ability to provide consent.

Exclusion Criteria

1. 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.
2. Patients with sick sinus syndrome, severe sinus bradycardia (heart rate\<50 beats/minute), grade II or above atrioventricular block, and no pacemaker implanted.
3. Unable to communicate due to coma, severe dementia, or language barriers prior to surgery.
4. Patients with severe liver dysfunction (Child Pugh C grade), renal dysfunction (preoperative dialysis), ASA grade V or expected survival ≤ 24 hours.
5. Heart transplant surgery
6. Surgery for congenital heart disease.
7. Deep hypothermic circulatory arrest surgery.
8. Already enrolled in other study patients.
9. Refuse to participate.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No