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Postoperative DeliriumPhase 3DREAMSNCT06619912

Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients

A Phase 3 study testing Dexmedetomidine nasal spray in people with Postoperative Delirium and Preoperative Sleep Disorder, run by Xijing Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 may be effective in reducing delirium. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dexmedetomidine nasal spray
Could I receive a placebo?
No, everyone receives an active treatment
How many people
686 participants
Where
1 siteChina
Study dates
3 Mar 2025to 8 Sep 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or older.
  • Cardiac surgery with cardiopulmonary bypass.
  • Ability to provide consent.

Who cannot join

  • 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.
Show all 9Show fewer
  • Deep hypothermic circulatory arrest surgery.
  • Already enrolled in other study patients.
  • Refuse to participate.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xijing Hospital

    Xi'an, Shaanxi, 710032

Other trials in China

About this study

Official title: Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients：a Single-center, Double- Blind, Controlled Trial

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.

Read the 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.

Being tested
Dexmedetomidine nasal spray
Keywords
postoperative delirium, preoperative sleep disorder, dexmedetomidine, cardiopulmonary coupling
Medical subject headings
Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmedetomidine nasal sprayDrug

    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.

Study groups in NCT06619912
Study groupRoleWhat they receive
Dexmedetomidine groupExperimentalThe Dexmedetomidine group will receive dexmedetomidine nasal spray （1.5ug/kg, ideal body weight) at the night before surgery and 30 minutes before induction.
Receives: Drug: Dexmedetomidine nasal spray
Control groupNo interventionIn the control group, the treatment is sodium chloride 0.9% nasal spray. Follows the same rules as in the experimental group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: within 1 week after operation

Secondary outcomes (8)

  1. 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

    Measured: 1week after surgery

  2. Delirium subtypes

    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

    Measured: 1week after surgery

  3. 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)

    Measured: 1week after surgery

  4. Hospital length of stay.

    Hospital length of stay.

    Measured: From the date of surgery until the date patient discharge from hospital, assessed up to 30 days]

  5. In- hospital mortality

    In- hospital mortality

    Measured: From the date of surgery until the date patient discharge from hospital, assessed up to 30 days]

  6. NRS score of sleep during the first night after surgery

    NRS score of sleep during the first night after surgery

    Measured: The first night after surgery

  7. Postoperative anxiety and depression

    Postoperative anxiety and depression are assessed using Hospital Anxiety and Depression Scale (HADS)

    Measured: 1week after surgery

  8. Pain intensity

    1. Pain intensity is assessed using the NRS at rest and during movement daily for 7 postoperative days

    Measured: 1week after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start3 Mar 2025
  3. Primary completion24 Aug 2026
  4. Study completion8 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
686 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06619912
Sponsor's protocol ID
KY20242259
Acronym
DREAMS
Status last verified
Sep 2026
First submitted
19 Sep 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underline the results reported in this article, after deidentification.

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.

    PubMed 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.

    PubMed 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.

    PubMed 42014143

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexmedetomidine nasal spray in people with Postoperative Delirium and Preoperative Sleep Disorder, run by Xijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative delirium occurrence (time frame: within 1 week after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06619912, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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