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NCT Number: NCT07579806

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine hydrochloride nasal spray

Drug

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

Drug

The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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]).

    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.

  2. 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.

    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.

  3. Incidence of adverse events

    Time frame: From administration of the investigational product up to 7 days postoperatively.

    Incidence of adverse events following administration of the investigational product.

  4. Subjective sleep quality

    Time frame: 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.

  5. NRS pain score

    Time frame: 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)

  6. The severity of postoperative delirium

    Time frame: 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.

  7. Duration of delirium

    Time frame: 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.

  8. Duration of Postoperative Hospital Stay (Days)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peng LI

CONTACT

[email protected]

+86 13668169590

Shaomao Jia

CONTACT

[email protected]

+86 13419213559

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study title

The Effect of Dexmedetomidine Nasal Spray on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Lung Resection

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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