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

29. oktober 2026 oppdatert av: Dong-Xin Wang, Peking University First Hospital

Impact of Intranasal Dexmedetomidine-esketamine Combination on Neurocognitive Recovery in Older Patients After Noncardiac Surgery: a Randomized, Double-blind, and Placebo-controlled Trial

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Postoperative neurocognitive disorders, including postoperative delirium (POD) and delayed neurocognitive recovery (dNCR), are common in older patients undergoing surgery and are associated with prolonged hospitalization, worse functional recovery, and increased mortality. Disturbed sleep is a modifiable contributor: perioperative sleep disruption may amplify neuroinflammation, pain, and opioid requirements, creating a feed-forward loop that promotes neurocognitive complications.

Dexmedetomidine, a highly selective α2-adrenergic agonist, mimics aspects of physiological non-rapid eye movement (NREM) sleep. Intranasal dexmedetomidine has been used to improve perioperative sleep in older patients. Esketamine, the S-enantiomer of ketamine, provides analgesia and has rapid antidepressant effects. Intranasal esketamine is approved for treatment-resistant depression. Combined use of subanesthetic doses of esketamine and dexmedetomidine shows synergy in analgesia and anxiolysis, with fewer neuropsychiatric adverse effects.

Combining low doses of both agents for intranasal administration therefore targets several mechanisms implicated in POD and dNCR simultaneously (sleep restoration, analgesia, anxiolysis, and potentially reduced opioid consumption) via a noninvasive route feasible on surgical wards. 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.

Studietype

Intervensjonell

Registrering (Antatt)

732

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100034

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: DEX-ESK group

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.
Legemiddel: 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.

Andre navn:
  • DEX-ESK group
Placebo komparator: Placebo group

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.
Legemiddel: 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.

Andre navn:
  • Placebo gruppe

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of delayed neurocognitive recovery (dNCR) on postoperative day 4.
Tidsramme: 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.
Up to 4 days after surgery.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of postoperative delirium within 3 days after surgery.
Tidsramme: Up to 3 days after surgery.

Delirium will be assessed twice daily during the first 3 postoperative days using the 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) in non-intubated patients and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) in intubated patients.
Up to 3 days after surgery.
Incidence of delayed neurocognitive recovery (dNCR) on postoperative day 30.
Tidsramme: At 30 days after surgery.

Cognitive function will be assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher scores indicating better function) before surgery and on postoperative day 30. Delayed neurocognitive recovery (dNCR) is defined as a decline from baseline of >1 SD in T-MoCA score.
At 30 days after surgery.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Peking University First Hospital

Etterforskere

  • Hovedetterforsker: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. september 2027

Datoer for studieregistrering

Først innsendt

29. oktober 2026

Først innsendt som oppfylte QC-kriteriene

29. oktober 2026

Først lagt ut (Faktiske)

4. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026R0664

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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