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NCT Number: NCT06619912

Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Postoperative delirium occurrence

    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.

Secondary outcomes

  1. Delirium severity measurement

    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

  2. Delirium subtypes

    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

  3. Duration of 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)

  4. Hospital length of stay.

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

    Hospital length of stay.

  5. In- hospital mortality

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

    In- hospital mortality

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

    Time frame: The first night after surgery

    NRS score of sleep during the first night after surgery

  7. Postoperative anxiety and depression

    Time frame: 1week after surgery

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

  8. Pain intensity

    Time frame: 1week after surgery

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

Other outcomes

  1. Postoperative occurence of AKI

    Time frame: 1week after surgery

    AKI occurrence was evaluated with KIDGO guideline during the 7 days following surgery.

  2. Plasma concentration of pTau-217

    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.

  3. Postoperative occurence of atrial fibrillation

    Time frame: 1week after surgery

    Postoperative occurence of atrial fibrillation

Study contacts

Contact information is provided by the study sponsor or research team.

Chong Lei, M.D., phd

CONTACT

[email protected]

86-18629011362

Zefei Zhang, M.D.

CONTACT

[email protected]

86-18811797795

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Acronym: DREAMS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
Jul 22, 2025

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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