Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients

NCT06619912 | Recruiting Phase 3

• 1 other identifier: KY20242259
• Study Type: interventional
• Target: 686
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Postoperative Delirium; Preoperative Sleep Disorder

Keywords

postoperative delirium; preoperative sleep disorder; dexmedetomidine; cardiopulmonary coupling

Outcome Measures

Primary Outcomes (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.

  within 1 week after operation

Secondary Outcomes (8)

• Delirium severity measurement

  1week after surgery

• Delirium subtypes

  1week after surgery

• Duration of delirium

  1week after surgery

• Hospital length of stay.

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

• In- hospital mortality

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

Other Outcomes (3)

• Postoperative occurence of AKI

  1week after surgery

• Plasma concentration of pTau-217

  24h after surgery

• Postoperative occurence of atrial fibrillation

  1week after surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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.

Dexmedetomidine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 29958125 BACKGROUND

• 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.

  PMID: 32682483 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chong Lei, M.D., phd

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chong Lei, M.D., phd

CONTACT

86-18629011362; crystalleichong@126.com

Zefei Zhang, M.D.

CONTACT

86-18811797795; zzfanita7@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 1, 2024
• Study Start: March 3, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: beginning 12 months

Locations

CN (1)