Study on the Correlation Between Plasma Orexin Levels During the Recovery Period and Emergence Delirium in Elderly Patients
17. august 2026 oppdatert av: Ruijin Hospital
Study on the Correlation Between Plasma Orexin Levels During the Recovery Period and Emergence Delirium in Elderly Patients: A Single-Center, Prospective, Observational Cohort Study
To explore the relationship between plasma orexin levels during the recovery period of elderly patients undergoing general anesthesia and the occurrence of emergence delirium, and to evaluate its sensitivity and specificity as an objective diagnostic indicator for emergence delirium
Studieoversikt
Status
Påmelding etter invitasjon
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
150
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200025
- Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
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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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
elderly patients undergoing general anesthesia
Beskrivelse
Inclusion Criteria:
- Age is greater than or equal to 60 years old
- It is planned to undergo elective non-cardiac surgery under general anesthesia, with the expected operation duration being greater than or equal to 2 hours
- ASA I-III
Exclusion Criteria:
- There was a clear diagnosis of mental illness before the surgery (such as schizophrenia, severe depression, etc.) or the patient had been using antidepressants or anti-psychotic drugs for a long time.
- Preoperative presence of sleep-wake disorder-related diseases (such as narcolepsy, untreated moderate to severe obstructive sleep apnea syndrome, etc.) or long-term use of orexin receptor antagonists or agonists
- Preoperatively, there was severe liver dysfunction (Child-Pugh grade B or C), severe renal dysfunction (estimated glomerular filtration rate eGFR < 30 ml/min/1.73㎡), and severe anemia (Hb < 80 g/L)
- Perform deep sedation for extubation, plan to transfer to the ICU, or experience severe complications during the recovery period (such as anaphylactic shock, laryngospasm, etc.)
- There are cases where individuals have severe visual or hearing impairments, or are aphasic, and thus are unable to cooperate in completing the cognitive assessment.
- Having a history of alcohol abuse or drug addiction
- Emergency surgery, neurosurgery surgery
- The researchers considered it inappropriate to include in this study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Emergence delirium group
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Ingen intervensjon: Observasjonskohort
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Non-Emergence delirium group
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Ingen intervensjon: Observasjonskohort
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Emergece Delirium
Tidsramme: During extubation and 20 minutes after extubation
|
The CAM-ICU scale is administered at extubation and 20 minutes post-extubation during the PACU stay.
A positive finding at either time point is defined as emergence delirium.
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During extubation and 20 minutes after extubation
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Plasma Orexin
Tidsramme: 30 minutes before anesthesia induction, after anesthesia induction but before surgical incision, 1 hour after surgical incision, at the time of discontinuation of volatile anesthetics, at extubation, and 20 minutes post-extubation
|
Peripheral venous blood samples (3 mL each) are collected at six time points: 30 minutes before anesthesia induction, after induction but before incision, 1 hour after incision, at volatile anesthetic discontinuation, at extubation, and 20 minutes post-extubation.
Samples are placed in EDTA tubes, stored at 2-8°C, centrifuged at 3000 rpm for 15 minutes at 4°C, and the separated plasma is stored at -80°C.
Plasma orexin-A levels are measured by ELISA by technicians blinded to group assignment.
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30 minutes before anesthesia induction, after anesthesia induction but before surgical incision, 1 hour after surgical incision, at the time of discontinuation of volatile anesthetics, at extubation, and 20 minutes post-extubation
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Delirium
Tidsramme: 5 days post- operation
|
Postoperative delirium is assessed twice daily (8:00-10:00 and 18:00-20:00) from postoperative day 1 through day 5 using the CAM/CAM-ICU scale.
A positive finding on any assessment is defined as the occurrence of postoperative delirium.
The severity of delirium is evaluated using the DRS-R-98.
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5 days post- operation
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EEG power in alpha band
Tidsramme: From PACU admission to 20 minutes post-extubation
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EEG power in alpha band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.
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From PACU admission to 20 minutes post-extubation
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EEG power in beta band
Tidsramme: From PACU admission to 20 minutes post-extubation
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EEG power in beta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.
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From PACU admission to 20 minutes post-extubation
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EEG power in theta band
Tidsramme: From PACU admission to 20 minutes post-extubation
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EEG power in theta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.
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From PACU admission to 20 minutes post-extubation
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EEG power in delta band
Tidsramme: From PACU admission to 20 minutes post-extubation
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EEG power in delta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.
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From PACU admission to 20 minutes post-extubation
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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 (Faktiske)
31. mars 2026
Primær fullføring (Antatt)
31. januar 2027
Studiet fullført (Antatt)
5. februar 2027
Datoer for studieregistrering
Først innsendt
21. juli 2026
Først innsendt som oppfylte QC-kriteriene
21. juli 2026
Først lagt ut (Faktiske)
24. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. august 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MR-31-26-052808
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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