Study on the Correlation Between Plasma Orexin Levels During the Recovery Period and Emergence Delirium in Elderly Patients
17. august 2026 opdateret af: 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
Studieoversigt
Status
Tilmelding efter invitation
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
150
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Emergence delirium group
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Ingen intervention: Observationskohorte
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Non-Emergence delirium group
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Ingen intervention: Observationskohorte
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Delirium
Tidsramme: 5 days post- operation
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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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
31. marts 2026
Primær færdiggørelse (Anslået)
31. januar 2027
Studieafslutning (Anslået)
5. februar 2027
Datoer for studieregistrering
Først indsendt
21. juli 2026
Først indsendt, der opfyldte QC-kriterier
21. juli 2026
Først opslået (Faktiske)
24. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. august 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MR-31-26-052808
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