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

NCT07579806 | Not Yet Recruiting Phase 4

• 1 other identifier: SPPH2025585
• Study Type: interventional
• Target: 264
• Locations: 0 countries
• Sites: N/A

Brief 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. 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)

Keywords

Dexmedetomidine Nasal Spray; Elderly (people aged 65 or more); Video-assisted thoracoscopic surgery (VATS); Lung resection procedures; Postoperative Delirium (POD)

Outcome Measures

Primary Outcomes (1)

• 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.

  postoperative days 1 through 3

Secondary Outcomes (8)

• Time from End of Surgery to Tracheal Extubation (Minutes)

  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)

  From patient admission to the PACU (immediately post-surgery) until PACU discharge, assessed up to 24 hours after PACU admission.

• Incidence of adverse events

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

• Subjective sleep quality

  postoperative days 1 through 3

• NRS pain score

  Before discharge from the PACU and on postoperative days 1 through 3.

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

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.

The nasal spray group (Group D) ：Dexmedetomidine hydrochloride nasal spray 100μg

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.

The control group (Group C)：Placebo nasal spray 100μg

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Peng LI

CONTACT

+86 13668169590; lipengmazui@163.com

Shaomao Jia

CONTACT

+86 13419213559; 670979499@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share