- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07722481
Preoperative Chronotype and Emergence Delirium in the Elderly
An Observational Study on the Influence of Preoperative Sleep Time Types on Postoperative Delirium in Elderly Patients
Emergence delirium (ED) is a prevalent and severe postoperative complication in elderly surgical patients. It can occur at any perioperative stage but most frequently develops during or immediately after emergence from general anesthesia. Characterized by acute agitation and confusion, ED manifests as sharp declines in attention and cognitive function, accompanied by impaired consciousness and disorganized thinking. As a common adverse event in the early postoperative period, ED occurs in up to 87% of critically ill patients, 10%-24% of adult general medical patients, 37%-46% of anesthetized general surgical patients, with the highest incidence of 50% observed in elderly surgical patients during early recovery in the Post-Anesthesia Care Unit (PACU). Anesthesiologists have long attached great importance to the harmful effects of ED on clinical outcomes, as ED elevates risks of postoperative hemorrhage and physical trauma, extends PACU monitoring duration and hospital length of stay, and increases postoperative complications, mortality and medical resource consumption.
Chronotype describes the behavioral manifestation of the endogenous 24-hour circadian timing system. In mammals, circadian rhythms are maintained and regulated by a complete clock system: the central master clock resides in the suprachiasmatic nucleus (SCN) of the hypothalamus, while peripheral clocks exist in organs such as the liver, lungs and skeletal muscle. Patients with delirium commonly suffer severe circadian disturbances, which are embodied in disordered sleep-wake cycles, abnormal secretion rhythms of melatonin and cortisol, and altered expression of clock genes. Chronotypes are conventionally divided into morning, evening and intermediate types. Previous observational studies have proven that chronotype correlates with numerous disorders including metabolic diseases, psychiatric illnesses, brain function, delirium and cognitive performance. Accumulated evidence supports an association between delirium and circadian rhythms, and suggests that circadian dysfunction contributes to the pathological development of delirium.
Nevertheless, few studies have investigated how chronotype affects ED in elderly patients. This study intends to explore the correlation between chronotype and postoperative ED in elderly surgical patients and compare ED incidence among patients with distinct chronotypes. The results of this research will offer scientific references for formulating targeted preventive measures against ED in elderly populations, lower postoperative ED rates, alleviate adverse postoperative events, and optimize long-term clinical prognosis.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400010
- The Second Affiliated Hospital of Chongqing Medical University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age of 65 years or older.
- Scheduled non-cardiac surgery under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Signed informed consent for surgical treatment.
Exclusion Criteria:
- Auditory or verbal impairment.
- Long-term use of psychotropic drugs or alcohol abuse.
- Pre-existing psychiatric disease or cognitive dysfunction.
- A medical history of cerebral infarction, dementia or hypoalbuminemia.
Withdrawal Criteria:
- Surgery duration less than 60 minutes
- Intraoperative blood transfusion
- Intraoperative hypothermia or hypotension
- Intraoperative administration of dexmedetomidine
- Postoperative transfer to intensive care unit
- Requirement for secondary surgical intervention
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
morning chronotype group
Patients with the Morningness-Eveningness Questionnaire Self-Assessment Version (MEQ-SA) scores ≥ 60
|
Emergence delirium was assessed at 30 minutes after admission to the post-anesthesia care unit (PACU) and at PACU discharge using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), a validated tool with high sensitivity and specificity for delirium detection.sment
Method for the Intensive Care Unit (CAM-ICU)
|
|
non-morning chronotype group
Patients with the Morningness-Eveningness Questionnaire Self-Assessment Version (MEQ-SA) scores < 60
|
Emergence delirium was assessed at 30 minutes after admission to the post-anesthesia care unit (PACU) and at PACU discharge using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), a validated tool with high sensitivity and specificity for delirium detection.sment
Method for the Intensive Care Unit (CAM-ICU)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of emergence delirium 1
Tidsramme: At 30 minutes after post-anesthesia care unit admission
|
Use CAM-ICU
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At 30 minutes after post-anesthesia care unit admission
|
|
Incidence of emergence delirium 2
Tidsramme: Within 5 minutes prior to post-anesthesia care unit discharge.
|
Use CAM-ICU
|
Within 5 minutes prior to post-anesthesia care unit discharge.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative CAM-ICU scores 1
Tidsramme: At 30 minutes after post-anesthesia care unit admission
|
Use CAM-ICU
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At 30 minutes after post-anesthesia care unit admission
|
|
Postoperative CAM-ICU scores 2
Tidsramme: Within 5 minutes prior to post-anesthesia care unit discharge.
|
Use CAM-ICU
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Within 5 minutes prior to post-anesthesia care unit discharge.
|
|
Postoperative pain scores 1
Tidsramme: At 30 minutes after post-anesthesia care unit admission
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Use the visual analogue scale(VAS)
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At 30 minutes after post-anesthesia care unit admission
|
|
Postoperative pain scores 2
Tidsramme: Within 5 minutes prior to post-anesthesia care unit discharge.
|
Use the visual analogue scale(VAS)
|
Within 5 minutes prior to post-anesthesia care unit discharge.
|
|
Hospital length of stay
Tidsramme: Up to 12 weeks
|
The period from when the patients enter the hospital until they leave the hospital
|
Up to 12 weeks
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NO. 2024-193
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