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Dexmedetomidine Nasal Spray on Postoperative Delirium in Elderly Thoracoscopic Lung Resection Patients

6 mei 2026 bijgewerkt door: Peng Li, Sichuan Provincial People's Hospital

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

264

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: The nasal spray group (Group D) ：Dexmedetomidine hydrochloride nasal spray 100μg
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.
Geneesmiddel: Dexmedetomidine hydrochloride nasal spray
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.
Placebo-vergelijker: The control group (Group C)：Placebo nasal spray 100μg
The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo.
Geneesmiddel: Placebo
The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The incidence of postoperative delirium (POD) within the first 3 days after surgery
Tijdsspanne: 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.
postoperative days 1 through 3

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time from End of Surgery to Tracheal Extubation (Minutes)
Tijdsspanne: 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]).
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.
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)
Tijdsspanne: From patient admission to the PACU (immediately post-surgery) until PACU discharge, assessed up to 24 hours after PACU admission.
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.
From patient admission to the PACU (immediately post-surgery) until PACU discharge, assessed up to 24 hours after PACU admission.
Incidence of adverse events
Tijdsspanne: From administration of the investigational product up to 7 days postoperatively.
Incidence of adverse events following administration of the investigational product.
From administration of the investigational product up to 7 days postoperatively.
Subjective sleep quality
Tijdsspanne: postoperative days 1 through 3
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.
postoperative days 1 through 3
NRS pain score
Tijdsspanne: Before discharge from the PACU and on postoperative days 1 through 3.
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)
Before discharge from the PACU and on postoperative days 1 through 3.
The severity of postoperative delirium
Tijdsspanne: postoperative days 1 through 3
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.
postoperative days 1 through 3
Duration of delirium
Tijdsspanne: Time from delirium onset to resolution, assessed up to 7 days postoperatively.
The period commencing from the day delirium was first assessed as positive until delirium was assessed as negative or the patient was discharged.
Time from delirium onset to resolution, assessed up to 7 days postoperatively.
Duration of Postoperative Hospital Stay (Days)
Tijdsspanne: From the day of surgery until formal hospital discharge, assessed up to 30 days after surgery.
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.
From the day of surgery until formal hospital discharge, assessed up to 30 days after surgery.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sichuan Provincial People's Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

23 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

12 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

6 mei 2026

Laatst geverifieerd

1 maart 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SPPH2025585

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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