The Effect of Circadian Clock System on Perioperative Cognitive Function of Elderly Patients
10 décembre 2019 mis à jour par: Yanchao Yang, Shengjing Hospital
Postoperative cognitive dysfunction (POCD) is a common postoperative complication in patients aged 65 and above.
It refers to the cognitive function changes such as memory decline and attention loss after anesthesia and surgery.
In serious cases, people may also experience personality changes and decline in social behavior ability, which will develop into irreversible cognitive impairment.Some studies reported that 25.8% of elderly patients presented POCD one week after non-cardiac surgery, and the incidence at 3 months after surgery was still 9.9%, which could increase the mortality in the first year after surgery.In recent years, studies have also proved that POCD is associated with patients' inability to perform their original jobs after non-cardiac surgery.Postoperative cognitive dysfunction seriously affects the clinical outcome, in addition to medical costs and other issues will bring an impact on the society and family.With the aging of the population, how to prevent cognitive dysfunction in elderly patients is a major challenge for perioperative management.There is a certain correlation between circadian rhythm and the dosage of general anesthesia, and postoperative sleep disturbance may be related to the effect of anesthesia and surgery on circadian rhythm.Preoperative sleep deprivation is known to be an independent risk factor for postoperative cognitive dysfunction (POCD), but the circadian mechanisms involved after general anesthesia are not yet clear
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
120
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Liaoning
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Shenyang, Liaoning, Chine, 110004
- Recrutement
- Junchao hospital Zhu
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Contact:
- Junchao h Zhu
- Numéro de téléphone: 18940257257 18940257257
- E-mail: zhujc@sj-hospital.org
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans à 90 ans (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- preoperative sleep disorders
- did not receive any preoperative chemoradiotherapy
- the duration of surgery ≧3 hours
Exclusion Criteria:
- History of schizophrenia
- epilepsy
- parkinson's disease or myasthenia gravis
- Critical illness (preoperative American society of anesthesiologists (ASA) ASA >III)
- severe liver insufficiency (ChildePugh grade C)
- severe renal insufficiency (preoperative dialysis)
- neurosurgery
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Day group
60 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group ( 8:00-12:00)
|
120 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) and in the Night Group (18:00-22:00)
|
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Autre: Night group
60 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Night Group (18:00-22:00)
|
120 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) and in the Night Group (18:00-22:00)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
postoperative sleep quality of one night before surgery
Délai: one night before the surgery
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use sleep monitor to test the sleep quality one night before surgery
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one night before the surgery
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postoperative sleep quality of first night after surgery
Délai: the first night after surgery
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use sleep monitor to test the sleep quality first night after surgery
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the first night after surgery
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postoperative sleep quality of third night after surgery
Délai: the third night after surgery
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use sleep monitor to test the sleep quality third night after surgery
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the third night after surgery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Preoperative cognitive function test
Délai: one day before surgery
|
use MMSE(Mini-mental state examination) scale to test the cognitive function one day before surgery.
MMSE(Mini-mental state examination) is a simple test assessing several categories, such as orientation to time and place, short term memory, recall, attention, calculation, language and visuo-spatial abilities.
Scores ranging from 30 to 24 usually indicate normal cognitive function, while lower scores suggest the presence of cognitive impairment: mild from 23 to 19, moderate from 18 to 10 and severe from 9 to 0
|
one day before surgery
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Postoperative cognitive function test of 6 weeks after surgery
Délai: 6 weeks after surgery
|
use MMSE(Mini-mental state examination) scale to test the cognitive function 6 weeks after surgery.
MMSE is a simple test assessing several categories, such as orientation to time and place, short term memory, recall, attention, calculation, language and visuo-spatial abilities.
Scores ranging from 30 to 24 usually indicate normal cognitive function, while lower scores suggest the presence of cognitive impairment: mild from 23 to 19, moderate from 18 to 10 and severe from 9 to 0
|
6 weeks after surgery
|
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Postoperative cognitive function test of 1 year after surgery
Délai: 1 year after surgery
|
use MMSE(Mini-mental state examination) scale to test the cognitive function 1 year after surgery.
MMSE(Mini-mental state examination) is a simple test assessing several categories, such as orientation to time and place, short term memory, recall, attention, calculation, language and visuo-spatial abilities.
Scores ranging from 30 to 24 usually indicate normal cognitive function, while lower scores suggest the presence of cognitive impairment: mild from 23 to 19, moderate from 18 to 10 and severe from 9 to 0
|
1 year after surgery
|
|
Postoperative cognitive function test of 3 years after surgery
Délai: 3 years after surgery
|
use MMSE(Mini-mental state examination) scale to test the cognitive function 3 years after surgery.
MMSE(Mini-mental state examination) is a simple test assessing several categories, such as orientation to time and place, short term memory, recall, attention, calculation, language and visuo-spatial abilities.
Scores ranging from 30 to 24 usually indicate normal cognitive function, while lower scores suggest the presence of cognitive impairment: mild from 23 to 19, moderate from 18 to 10 and severe from 9 to 0
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3 years after surgery
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 janvier 2020
Achèvement primaire (Anticipé)
30 novembre 2022
Achèvement de l'étude (Anticipé)
31 décembre 2022
Dates d'inscription aux études
Première soumission
10 décembre 2019
Première soumission répondant aux critères de contrôle qualité
10 décembre 2019
Première publication (Réel)
11 décembre 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 décembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 décembre 2019
Dernière vérification
1 décembre 2019
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- circadian clock
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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