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New treatment option for Postoperative Delirium
Official title Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients
ClinicalTrials.gov ID: NCT06619912
What this study is testing
What is Dexmedetomidine nasal spray?
Dexmedetomidine nasal spray is an investigational medicine, being studied as a potential treatment for postoperative delirium.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged 18 years or older.
- Cardiac surgery with cardiopulmonary bypass.
- Ability to provide consent.
You likely can't join if
- Preoperative schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, history of neurosurgery, or Mini-mental State Examination(MMSE) score...
- Patients with sick sinus syndrome, severe sinus bradycardia (heart rate\<50 beats/minute), grade II or above atrioventricular block, and no pacemaker...
- 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.
See the full eligibility criteria
- Aged 18 years or older.
- Cardiac surgery with cardiopulmonary bypass.
- Ability to provide consent.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.