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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorSichuan Provincial People's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dexmedetomidine hydrochloride nasal spray
  • Placebo

Treatment groups

264 Participants
are divided into 2 treatment groups

Locations

This trial has no locations