Postoperative Delirium (POD)Phase 4NCT07579806
Dexmedetomidine Nasal Spray on Postoperative Delirium in Elderly Thoracoscopic Lung Resection Patients
A Phase 4 study testing Dexmedetomidine hydrochloride nasal spray in people with Postoperative Delirium (POD), run by Sichuan Provincial People's Hospital.
Trial summary
This clinical trial is designed to observe the effect of dexmedetomidine nasal spray on the incidence of postoperative delirium in elderly patients undergoing thoracoscopic lung resection. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium (POD)
- What is being tested?
- Dexmedetomidine hydrochloride nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Dexmedetomidine Nasal Spray on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Lung Resection
This clinical trial is designed to observe the effect of dexmedetomidine nasal spray on the incidence of postoperative delirium in elderly patients undergoing thoracoscopic lung resection. Eligible elderly patients scheduled for thoracoscopic lung resection will be randomly divided into two groups: the dexmedetomidine group will receive dexmedetomidine hydrochloride nasal spray, while the placebo group will be administered an equivalent volume of placebo nasal spray. The primary outcome is the incidence of postoperative delirium within 3 days after surgery. Secondary outcomes include the severity and duration of delirium, as well as postoperative pain, subjective sleep quality, and the incidence of adverse events, which will be compared between the two groups to evaluate the safety and efficacy of dexmedetomidine nasal spray.
- Conditions
- Postoperative Delirium (POD)
- Being tested
- Dexmedetomidine hydrochloride nasal spray, Placebo
- Keywords
- Dexmedetomidine Nasal Spray, Elderly (people aged 65 or more), Video-assisted thoracoscopic surgery (VATS), Lung resection procedures, Postoperative Delirium (POD)
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine hydrochloride nasal sprayDrug
The nasal spray group (Group D) trial medication specification is dexmedetomidine hydrochloride nasal spray at 25μg per spray. Two sprays are administered into each nostril, totalling 100μg of dexmedetomidine.
PlaceboDrug
The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo.
| Study group | Role | What they receive |
|---|---|---|
| The nasal spray group (Group D) ：Dexmedetomidine hydrochloride nasal spray 100μg | Experimental | In the nasal spray group (Group D), the investigational product is dexmedetomidine hydrochloride nasal spray with a strength of 25 μg per spray. Two sprays will be administered into each nostril, resulting in a total dexmedetomidine dose of 100 μg. Receives: Drug: Dexmedetomidine hydrochloride nasal spray |
| The control group (Group C)：Placebo nasal spray 100μg | Placebo comparator | The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative delirium (POD) within the first 3 days after surgery
Patients will be assessed twice daily using the 3-Minute Delirium Assessment Scale (3D-CAM) on postoperative days 1 through 3.
Measured: postoperative days 1 through 3
Secondary outcomes (8)
Time from End of Surgery to Tracheal Extubation (Minutes)
The time interval, measured in minutes, between the surgeon's confirmed end of surgery (defined as completion of final wound closure) and complete removal of the tracheal tube from the patient's airway, documented via the official electronic anesthesia record.
Measured: From the immediate end of surgery until successful tracheal extubation, assessed up to 2 hours after surgery completion (prior to discharge from the Post-Anesthesia Care Unit [PACU]).
Duration of Post-Anesthesia Care Unit (PACU) Stay (Minutes)
The time interval, measured in minutes, between two standardized, timestamped endpoints: 1. Start point: The time of patient admission to the PACU, defined as the time when the patient is transferred into the PACU and connected to standard vital sign monitoring; 2. End point: The time of patient discharge from the PACU, defined as the time when the patient physically exits the PACU after meeting institutional discharge criteria. Data is prospectively documented in the official electronic anesthesia/PACU medical record.
Measured: From patient admission to the PACU (immediately post-surgery) until PACU discharge, assessed up to 24 hours after PACU admission.
Incidence of adverse events
Incidence of adverse events following administration of the investigational product.
Measured: From administration of the investigational product up to 7 days postoperatively.
Subjective sleep quality
Patient-reported subjective sleep quality, assessed daily using the 11-point Numerical Rating Scale (NRS, 0 = best sleep, 10 = worst sleep) on postoperative days 1-3.
Measured: postoperative days 1 through 3
NRS pain score
Pain score will be assessed using the Numerical Rating Scale (NRS) before discharge from the post-anesthesia care unit (PACU) and daily on postoperative days 1-3. (0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain)
Measured: Before discharge from the PACU and on postoperative days 1 through 3.
The severity of postoperative delirium
Delirium severity will be assessed using the Memorial Delirium Assessment Scale (MDAS) in patients with positive delirium on postoperative days 1-3. The MDAS consists of 10 items with a total score of 30; the severity of delirium is defined as the maximum MDAS score obtained during postoperative days 1-3.
Measured: postoperative days 1 through 3
Duration of delirium
The period commencing from the day delirium was first assessed as positive until delirium was assessed as negative or the patient was discharged.
Measured: Time from delirium onset to resolution, assessed up to 7 days postoperatively.
Duration of Postoperative Hospital Stay (Days)
Defined as the total number of calendar days from the day of index surgery to the day of hospital discharge. Discharge is defined as the time when the patient is formally discharged and physically leaves the hospital facility, recorded in the electronic hospital medical record.
Measured: From the day of surgery until formal hospital discharge, assessed up to 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Li, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579806
- Sponsor's protocol ID
- SPPH2025585
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine Nasal Spray on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Lung Resection
- ClinicalTrials.gov ID
- NCT07579806
- Acronym / sponsor ID
- SPPH2025585
- Conditions
- Postoperative Delirium (POD)
- Keywords
- Dexmedetomidine Nasal Spray, Elderly (people aged 65 or more), Video-assisted thoracoscopic surgery (VATS), Lung resection procedures, Postoperative Delirium (POD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is designed to observe the effect of dexmedetomidine nasal spray on the incidence of postoperative delirium in elderly patients undergoing thoracoscopic lung resection. Eligible elderly patients scheduled for thoracoscopic lung resection will be randomly divided into two groups: the dexmedetomidine group will receive dexmedetomidine hydrochloride nasal spray, while the placebo group will be administered an equivalent volume of placebo nasal spray. The primary outcome is the incidence of postoperative delirium within 3 days after surgery. Secondary outcomes include the severity and duration of delirium, as well as postoperative pain, subjective sleep quality, and the incidence of adverse events, which will be compared between the two groups to evaluate the safety and efficacy of dexmedetomidine nasal spray.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The nasal spray group (Group D) ：Dexmedetomidine hydrochloride nasal spray 100μg | Experimental | Drug: Dexmedetomidine hydrochloride nasal sprayIn the nasal spray group (Group D), the investigational product is dexmedetomidine hydrochloride nasal spray with a strength of 25 μg per spray. Two sprays will be administered into each nostril, resulting in a total dexmedetomidine dose of 100 μg. |
| The control group (Group C)：Placebo nasal spray 100μg | Placebo comparator | Drug: PlaceboThe control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine hydrochloride nasal sprayThe nasal spray group (Group D) trial medication specification is dexmedetomidine hydrochloride nasal spray at 25μg per spray. Two sprays are administered into each nostril, totalling 100μg of dexmedetomidine. | Drug | The nasal spray group (Group D) ：Dexmedetomidine hydrochloride nasal spray 100μg |
| PlaceboThe control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo. | Drug | The control group (Group C)：Placebo nasal spray 100μg |
Primary outcome
The incidence of postoperative delirium (POD) within the first 3 days after surgery
Time frame: postoperative days 1 through 3
Patients will be assessed twice daily using the 3-Minute Delirium Assessment Scale (3D-CAM) on postoperative days 1 through 3.
8 secondary outcomes
Time from End of Surgery to Tracheal Extubation (Minutes)
Time frame: From the immediate end of surgery until successful tracheal extubation, assessed up to 2 hours after surgery completion (prior to discharge from the Post-Anesthesia Care Unit [PACU]).
Duration of Post-Anesthesia Care Unit (PACU) Stay (Minutes)
Time frame: From patient admission to the PACU (immediately post-surgery) until PACU discharge, assessed up to 24 hours after PACU admission.
Incidence of adverse events
Time frame: From administration of the investigational product up to 7 days postoperatively.
Subjective sleep quality
Time frame: postoperative days 1 through 3
NRS pain score
Time frame: Before discharge from the PACU and on postoperative days 1 through 3.
The severity of postoperative delirium
Time frame: postoperative days 1 through 3
Duration of delirium
Time frame: Time from delirium onset to resolution, assessed up to 7 days postoperatively.
Duration of Postoperative Hospital Stay (Days)
Time frame: From the day of surgery until formal hospital discharge, assessed up to 30 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine hydrochloride nasal spray in people with Postoperative Delirium (POD), run by Sichuan Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng LI (+86 13668169590, lipengmazui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative delirium (POD) within the first 3 days after surgery (time frame: postoperative days 1 through 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.