- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01179438
Effect of Dexmedetomidine on Microcirculation in Patients Undergoing Extracorporeal Shock Wave Lithotripsy
Dexmedetomidine administration for minor procedure, such as extracorporeal shock wave lithotripsy, provides good quality of sedation and analgesia. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist which causes sedative effects and reduces opioid requirements in the perioperative period. Extracorporeal shock wave lithotripsy may cause pain and result in tachycardia and vasoconstriction-related hypertension. Surgical or procedural stress may induce inflammation and it may cause further microthrombosis. Both vasoconstriction and microthrombosis will alter the microcirculatory status. Dysfunction of microcirculation may impair tissue perfusion and result in organ dysfunction. Dexmedetomidine may induce vasodilation by slow intravenous infusion for sedation. Dexmedetomidine may also reduce inflammation. After reviewing the literature, the investigators found that the effect of dexmedetomidine on microcirculation was not well investigated. By application of the non-invasive technique of sidestream dark field imaging, the investigators can investigate the vessel density, percentage of perfused vessels, and microvascular flow index on sublingual vessels.
The goal of this study is to identify the effect of dexmedetomidine on sublingual microcirculation in patient undergoing extracorporeal shock wave lithotripsy.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
-
Taipei, Taiwan, 100
- National Taiwan University Hospital, anesthesiology department
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patient who is older than 18 years old and less than 75 years old
- Patient who receive extraproporeal shock wave lithotripsy with ASA class I or II
- Patient who has understood the inform consent and agree to participate this study
Exclusion Criteria:
- Patient's hemodynamic status is unstable in spite of adequate management or presence of signs of shock
- Patient who has a past history of allergy to s dexmedetomidine
- Patient who has history of cardiovascular, renal or hepatic dysfunction
- Patient who has participated in any other investigational study of other drugs currently
- Female patient who is pregnant or considers breast feeding currently
- Patient who has suspected full stomach
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Microcirculation status
Tidsramme: 120min
|
Microcirculation examination
|
120min
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Analgetika, ikke-narkotisk
- Adrenerge alfa-2-receptoragonister
- Adrenerge alfa-agonister
- Adrenerge agonister
- Hypnotika og beroligende midler
- Dexmedetomidin
Andre undersøgelses-id-numre
- 201003036M
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