- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03162692
Preoperative Anxiety's Incidence and Related Factors in Surgical Patients
19. maj 2017 opdateret af: Jin Dong Liu, Xuzhou Medical University
Preoperative anxiety is often described as an uncomfortable, tense unpleasant mood before surgery, an emotional response to a potential challenge or threat to reality.
Data show that adult patients with preoperative anxiety rate of 30-40%.
The main reason for the occurrence of patients for surgery, anesthesia and other factors of fear.
Preoperative anxiety itself is not a mental illness, but studies have confirmed that the occurrence of preoperative anxiety and postoperative complications were positively correlated, and the existence of preoperative anxiety in patients with conventional postoperative analgesic effect is poor.
At present, there are still few studies on the relationship between preoperative anxiety and postoperative complications and analgesia.
At the same time, there is a lack of large sample size to study the incidence of preoperative anxiety and its related predictors.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Surgical patients often have varying degrees of preoperative anxiety.The aim of this study was to determine the incidence of preoperative anxiety and related predictors, and to evaluate the effect of anxiety on anesthesia and postoperative pain and prognosis.
The study also showed that prostaglandin, catecholamines, cortex Effects of alcohol and inflammatory cell level on postoperative pain in patients with preoperative anxiety.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
2000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jindong Liu, M.S
- Telefonnummer: +86-13951355136
- E-mail: liujindong1818@163.com
Studiesteder
-
-
Jiangsu
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XuZhou, Jiangsu, Kina, 221000
- Rekruttering
- The Affiliated Hospital of Xuzhou Medical University
-
Kontakt:
- Jindong Liu, M.S
- Telefonnummer: +86-13951355136
- E-mail: liujindong1818@163.com
-
-
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
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
2000 patients undergoing elective general anesthesia in surgery in Xuzhou Medical University patients.
Beskrivelse
Inclusion Criteria:
- Age 18-70 years old
- Sign that informed consent is willing to participate in the study
- Education: primary school and above
- 1 days after elective general anesthesia surgery
- ASA score grade I-III
Exclusion Criteria:
- Emergency surgery
- Severe mental illness patients (such as anxiety, depression, schizophrenia, etc.)
- Taking anti-anxiety or antidepressants (benzodiazepines, tricyclic antidepressants, selective serotonin inhibitors, monoamine oxidase inhibitors, etc.)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Anxiety level
Tidsramme: All patients are evaluated one day before surgery
|
as measured by STAI (state-trait anxiety questionnaire)
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All patients are evaluated one day before surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
VAS pain score
Tidsramme: at 3 hours, 6 hours, 24 hours, 48 hours after surgery
|
as measured by visual smileys scale
|
at 3 hours, 6 hours, 24 hours, 48 hours after surgery
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
blood inflammation index
Tidsramme: Extraction of arterial blood before anesthesia induction
|
extraction of patients with arterial blood to laboratory tests
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Extraction of arterial blood before anesthesia induction
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jindong Liu, M.S, The Affiliated Hospital of Xuzhou Medical University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Lieb K, Fiebich BL, Berger M. [Substance P receptor antagonists--a new antidepressive and anxiolytic mechanism?]. Nervenarzt. 2000 Sep;71(9):758-61. doi: 10.1007/s001150050661. German.
- Maki Y. [A behavioral and neurochemical study on the mechanism of the anxiolytic effect of monoamine oxidase inhibitors]. Hokkaido Igaku Zasshi. 2001 May;76(3):133-42. Japanese.
- Yamauchi M, Hiraoka S, Imanishi T. [Role of the serotonergic nervous system in anxiety disorders and the anxiolytic mechanism of selective serotonin reuptake inhibitors]. Nihon Shinkei Seishin Yakurigaku Zasshi. 2006 Nov;26(5-6):193-8. Japanese.
- Matsumoto K, Puia G, Dong E, Pinna G. GABA(A) receptor neurotransmission dysfunction in a mouse model of social isolation-induced stress: possible insights into a non-serotonergic mechanism of action of SSRIs in mood and anxiety disorders. Stress. 2007 Mar;10(1):3-12. doi: 10.1080/10253890701200997.
- Herrera-Ruiz M, Gonzalez-Carranza A, Zamilpa A, Jimenez-Ferrer E, Huerta-Reyes M, Navarro-Garcia VM. The standardized extract of Loeselia mexicana possesses anxiolytic activity through the gamma-amino butyric acid mechanism. J Ethnopharmacol. 2011 Nov 18;138(2):261-7. doi: 10.1016/j.jep.2011.09.010. Epub 2011 Sep 16.
- Mico JA, Prieto R. Elucidating the mechanism of action of pregabalin: alpha(2)delta as a therapeutic target in anxiety. CNS Drugs. 2012 Aug 1;26(8):637-48. doi: 10.2165/11634510-000000000-00000.
- O'Donovan A, Slavich GM, Epel ES, Neylan TC. Exaggerated neurobiological sensitivity to threat as a mechanism linking anxiety with increased risk for diseases of aging. Neurosci Biobehav Rev. 2013 Jan;37(1):96-108. doi: 10.1016/j.neubiorev.2012.10.013. Epub 2012 Nov 2.
- Fan JM, Chen XQ, Du JZ. Prenatal stress, anxiety and depression: a mechanism involving CRH peptide family. Neuro Endocrinol Lett. 2014;35(6):429-39.
- He W, Zhou Q, Yu S, Cai D, Wang Q, Zhang X, Huang WQ. [Mechanism on atrial natriuretic peptide receptor in anti-anxiety with acupuncture based on its tranquilizing effect]. Zhongguo Zhen Jiu. 2015 Jan;35(1):101-4. Chinese.
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)
1. april 2017
Primær færdiggørelse (Forventet)
1. februar 2018
Studieafslutning (Forventet)
1. februar 2018
Datoer for studieregistrering
Først indsendt
18. maj 2017
Først indsendt, der opfyldte QC-kriterier
19. maj 2017
Først opslået (Faktiske)
22. maj 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. maj 2017
Sidst verificeret
1. maj 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- XYFY2017-KL021-01
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