Intranasal Dexmedetomidine-esketamine Combination and Postoperative Cognitive Recovery in Older Patients

NCT07914803 · tracked via the Priya Life Science China tracker

Sponsor

Peking University First Hospital

Phase

Phase 4

Started

2026-11

Last updated

2026-11-04

Condition(s) studied

Older PatientsNoncardiac SurgeryDexmedetomidineEsketamineIntranasal AdministrationPerioperative Neurocognitive Disorders

Investigational drug(s) / intervention(s)

Intranasal dexmedetomidine-esketamine combinationIntranasal placebo (0.9% saline)

Intranasal dexmedetomidine-esketamine combination: Participants in this group will receive intranasal administration of a dexmedetomidine-esketamine combination at bedtime (8-9 pm) three times: the night before surgery, the night of surgery, and the first postoperative night.

Intranasal placebo (0.9% saline): Participants in this group will receive intranasal administration of placebo (0.9% saline) at bedtime (8-9 pm) three times: the night before surgery, the night of surgery, and the first postoperative night.

Study summary

Postoperative neurocognitive disorders, including postoperative delirium (POD) and delayed neurocognitive recovery (dNCR), are common in older patients undergoing surgery and are associated with worse outcomes. Intranasal dexmedetomidine, esketamine, and their combination have been used in clinical practice to improve sleep quality and analgesia. A preliminary study suggested lower rates of emergence delirium and POD/dNCR in older patients receiving perioperative intranasal dexmedetomidine-esketamine. This randomized controlled trial is designed to test the hypothesis that perioperative administration of an intranasal dexmedetomidine-esketamine combination improves neurocognitive recovery in older patients undergoing noncardiac surgery.

Eligibility

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age ≥65 years. 2. Scheduled to undergo noncardiac surgery under general anesthesia with an expected operative duration \>1 hour. 3. Planned hospital stay of at least 1 day. Exclusion Criteria: 1. Nasal disease precluding intranasal administration (e.g., rhinitis, nasal polyps, or nasal congestion of any cause). 2. Pre-existing schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis. 3. Inability to communicate preoperatively due to coma, severe dementia, or language disorder. 4. History of craniocerebral injury or neurosurgery. 5. Pre-existing sleep-disordered breathing (diagnosed sleep apnea or high risk of moderate-to-severe sleep apnea on the STOP-Bang questionnaire). 6. History of hyperthyroidism or pheochromocytoma. 7. Preoperative LVEF \<30%, sick sinus syndrome, severe sinus bradycardia (heart rate \<50 beats/min), or second-degree or higher atrioventricular block without a pacemaker. 8. Severe hepatic dysfunction (Child-Pugh class C), severe renal impairment requiring preoperative dialysis, or ASA physical status ≥IV. 9. Planned postoperative ICU admission. 10. Known allergy or hypersensitivity to dexmedetomidine and/or esketamine. 11. Any other condition that, in the judgment of the investigator, makes the patient unsuitable for enrollment.

Primary outcome measure(s)

Incidence of delayed neurocognitive recovery (dNCR) on postoperative day 4. — Up to 4 days after surgery.
Cognitive function will be assessed with the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher scores indicating better function) before surgery and on postoperative day 4 or at hospital discharge, whichever occurs first. Delayed neurocognitive recovery (dNCR) is defined as a decline from baseline of \>1 SD in MoCA score.

Trial sites (1)

Facility	City	Region	Status
Peking University First Hospital	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07914803 on ClinicalTrials.gov ↗ ← All trials in China