Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization
6 maart 2017 bijgewerkt door: Nan Jiang
Effects of Dexmedetomidine on Post-operative Blood Pressure in Patients Undergoing Brain Arteriovenous Malformation Embolization
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization.
The patients were randomized allocated to either Dexmedetomidine group or Control group.
Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline.
Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization.
The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number.
Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline.
Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.
Studietype
Ingrijpend
Inschrijving (Verwacht)
30
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Nan Jiang, PhD
- Telefoonnummer: 86 20 28823350
- E-mail: NJiang_sysu@126.com
Studie Locaties
-
-
Guangdong
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Guangzhou, Guangdong, China, 510080
- Werving
- the First Affiliated Hospital of Sun Yetsen University
-
Contact:
- Yi Liu, Master
- Telefoonnummer: +86 13632391455
- E-mail: liuyisysu@126.com
-
Contact:
- Nan Jiang, professor
- Telefoonnummer: +86 20 28823350
- E-mail: NJiang_sysu@126.com
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- patients undergoing brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.
Exclusion Criteria:
- abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Dexmedetomidine
Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.
|
1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.
Andere namen:
|
|
Placebo-vergelijker: Control group
Normal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly.
|
equal volume of normal saline was administered intravenously constantly after tracheal extubation.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
urapidil consumption
Tijdsspanne: the end of the 6th hour after tracheal extubation
|
urapidil consumption was recorded by nurses every hour
|
the end of the 6th hour after tracheal extubation
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
urapidil consumption on POD1
Tijdsspanne: the total consumption of urapidil on post-operative day 1.
|
urapidil consumption was recorded by nurses every hour
|
the total consumption of urapidil on post-operative day 1.
|
|
urapidil consumption on POD2
Tijdsspanne: the total consumption of urapidil on post-operative day 2.
|
urapidil consumption was recorded by nurses every hour
|
the total consumption of urapidil on post-operative day 2.
|
|
Visual Analogue score
Tijdsspanne: the end of the 6th hour after tracheal extubation
|
visual analogue score was measured by visual analogue scale
|
the end of the 6th hour after tracheal extubation
|
|
Visual Analogue score at 24th hour
Tijdsspanne: the end of the 24th hour after tracheal extubation
|
visual analogue score was measured by visual analogue scale
|
the end of the 24th hour after tracheal extubation
|
|
Visual Analogue score at 48th hour
Tijdsspanne: the end of the 48th hour after tracheal extubation
|
visual analogue score was measured by visual analogue scale
|
the end of the 48th hour after tracheal extubation
|
|
Quality of Recovery Score
Tijdsspanne: the end of the 6th hour after tracheal extubation
|
Quality of Recovery Score was measured by a 15-item quality of recovery scale
|
the end of the 6th hour after tracheal extubation
|
|
Quality of Recovery Score at 24th hour
Tijdsspanne: the end of the 24th hour after tracheal extubation
|
Quality of Recovery Score was measured by a 15-item quality of recovery scale
|
the end of the 24th hour after tracheal extubation
|
|
Quality of Recovery Score at 48th hour
Tijdsspanne: the end of the 48th hour after tracheal extubation
|
Quality of Recovery Score was measured by a 15-item quality of recovery scale
|
the end of the 48th hour after tracheal extubation
|
|
Analgesics consumption
Tijdsspanne: the end of the 6th hour after tracheal extubation
|
Analgesics consumption was recorded by nurse every hour
|
the end of the 6th hour after tracheal extubation
|
|
Analgesics consumption on POD1
Tijdsspanne: the total consumption of urapidil on post-operative day 1.
|
Analgesics consumption was recorded by nurse every hour
|
the total consumption of urapidil on post-operative day 1.
|
|
Analgesics consumption on POD2
Tijdsspanne: the total consumption of urapidil on post-operative day 2.
|
Analgesics consumption was recorded by nurse every hour
|
the total consumption of urapidil on post-operative day 2.
|
|
Bradycardia
Tijdsspanne: the end of the 6th hour after tracheal extubation
|
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
|
the end of the 6th hour after tracheal extubation
|
|
Bradycardia at 24th hour
Tijdsspanne: the end of the 24th hour after tracheal extubation
|
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
|
the end of the 24th hour after tracheal extubation
|
|
Bradycardia at 48th hour
Tijdsspanne: the end of the 48th hour after tracheal extubation
|
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
|
the end of the 48th hour after tracheal extubation
|
|
PONV
Tijdsspanne: the end of the 6th hour after tracheal extubation
|
post-operative nausea and vomiting (PONV) was recorded by nurse
|
the end of the 6th hour after tracheal extubation
|
|
PONV at 24th hour
Tijdsspanne: the end of the 24th hour after tracheal extubation
|
post-operative nausea and vomiting (PONV) was recorded by nurse
|
the end of the 24th hour after tracheal extubation
|
|
PONV at 48th hour
Tijdsspanne: the end of the 48th hour after tracheal extubation
|
post-operative nausea and vomiting (PONV) was recorded by nurse
|
the end of the 48th hour after tracheal extubation
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2016
Primaire voltooiing (Verwacht)
31 december 2017
Studie voltooiing (Verwacht)
31 december 2017
Studieregistratiedata
Eerst ingediend
6 maart 2017
Eerst ingediend dat voldeed aan de QC-criteria
6 maart 2017
Eerst geplaatst (Werkelijk)
9 maart 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 maart 2017
Laatste update ingediend die voldeed aan QC-criteria
6 maart 2017
Laatst geverifieerd
1 maart 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hart-en vaatziekten
- Vaatziekten
- Cardiovasculaire afwijkingen
- Vasculaire misvormingen
- Aangeboren afwijkingen
- Arterioveneuze misvormingen
- Fysiologische effecten van medicijnen
- Adrenerge middelen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Depressiva van het centrale zenuwstelsel
- Agenten van het perifere zenuwstelsel
- Pijnstillers
- Sensorische systeemagenten
- Pijnstillers, niet-narcotisch
- Adrenerge alfa-2-receptoragonisten
- Adrenerge alfa-agonisten
- Adrenerge agonisten
- Hypnotica en sedativa
- Dexmedetomidine
Andere studie-ID-nummers
- NJiang2016-001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
the IPD will not be shared with others, since following investigations based on this trial is about to start.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .