Nasal spray may curb Post-Surgery confusion in seniors
NCT ID NCT07579806
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a nasal spray containing dexmedetomidine can reduce the chance of postoperative delirium (sudden confusion) in people 65 and older after lung surgery. About 264 participants will be randomly assigned to get either the drug or a placebo spray before surgery. Researchers will track confusion, pain, sleep quality, and side effects for three days after the operation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dexmedetomidine hydrochloride nasal spray
- What this could lead to
- If it works, this could offer a simple, non-invasive way to lower the risk of confusion after lung surgery in older adults.
- What could go wrong
- This is a single, mid-sized trial. The effect may be small or not better than placebo, and side effects like low blood pressure or slow heart rate are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 264 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status II-III. * Age ≥ 65 years, with no gender restriction. * Patients scheduled for elective thoracoscopic lung resection under general anesthesia, with an expected operative duration of 1-4 hours. * Body mass index (BMI) between 18 kg/m² and 30 kg/m². Exclusion Criteria: * Known hypersensitivity to dexmedetomidine hydrochloride or any of the excipients in the investigational product. * Pre-existing nasal conditions, nasal surgery, or nasal allergies that may significantly impair nasal drug absorption (e.g., chronic nasal congestion, rhinorrhea, epistaxis, nasal anatomical abnormalities, or mucosal pathology affecting absorption). * History of cranial trauma. * Pre-existing diagnosis or clinical suspicion of neurocognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \< 24. * History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis. * History of alcohol or substance abuse/dependence. * Left ventricular ejection fraction \< 30%; sick sinus syndrome; severe sinus bradycardia (\< 50 bpm); or second- or higher-degree atrioventricular block without permanent pacemaker implantation. * History of myocardial infarction, unstable angina, severe cardiac arrhythmia, or decompensated cardiac insufficiency. * Asthma, emphysema, chronic bronchitis, or chronic obstructive pulmonary disease (COPD) considered inappropriate for study participation by the investigator. * Severe hepatic impairment (Child-Pugh Class C). * Severe renal dysfunction requiring preoperative dialysis. * Inability to provide valid informed consent due to cultural background, language barrier, or cognitive impairment. * Refusal to sign the informed consent form. * Other conditions deemed inappropriate for study participation by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A heartbeat clue to Post-Surgery confusion in seniors?
- A simple eye mask might protect sleep and calm confusion after heart surgery
- Can a painkiller shield older hearts from Post-Surgery confusion?
- Could deep breaths before surgery ward off Post-Op confusion?
- Can surgery for stomach or esophageal cancer cloud the mind?