Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients (DREAMS)

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium; Preoperative Sleep Disorder
• Intervention / Treatment: Drug: Dexmedetomidine nasal spray

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.

• Study Type: Interventional
• Enrollment (Estimated): 686
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zefei Zhang, M.D.; Phone Number: 86-18811797795; Email: zzfanita7@163.com
• Study Contact Backup: Name: Chong Lei, M.D., phd; Phone Number: 86-18629011362; Email: crystalleichong@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Chong Lei, MD & phD; Phone Number: 86-18629011362; Email: crystalleichong@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; In the control group, the treatment is sodium chloride 0.9% nasal spray. Follows the same rules as in the experimental group.
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 1 week after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In- hospital mortality	In- hospital mortality	From the date of surgery until the date patient discharge from hospital, assessed up to 30 days]
Hospital length of stay.	Hospital length of stay.	From the date of surgery until the date patient discharge from hospital, assessed up to 30 days]
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	1week after surgery
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)	1week after surgery
NRS score of sleep during the first night after surgery	NRS score of sleep during the first night after surgery	The first night after surgery
Postoperative anxiety and depression	Postoperative anxiety and depression are assessed using Hospital Anxiety and Depression Scale (HADS)	1week after surgery
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	1week after surgery
Pain intensity	1) Pain intensity is assessed using the NRS at rest and during movement daily for 7 postoperative days	1week after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative occurence of AKI	AKI occurrence was evaluated with KIDGO guideline during the 7 days following surgery.	1week after surgery
Plasma concentration of pTau-217	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.	24h after surgery
Postoperative occurence of atrial fibrillation	Postoperative occurence of atrial fibrillation	1week after surgery

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Chong Lei, M.D., phd, Xijing Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 28, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: dexmedetomidine; postoperative delirium; preoperative sleep disorder; cardiopulmonary coupling
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium; Parasomnias; Sleep Wake Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: KY20242259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underline the results reported in this article, after deidentification.
• IPD Sharing Time Frame: beginning 12 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No