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Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization

6. marts 2017 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510080
        • Rekruttering
        • the First Affiliated Hospital of Sun Yetsen University
        • Kontakt:
        • Kontakt:

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dexmedetomidine
Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.
Medicin: Dexmedetomidine
1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.
Andre navne:
  • DEX
Placebo komparator: 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.
Andet: normal saline
equal volume of normal saline was administered intravenously constantly after tracheal extubation.
Andre navne:
  • NS

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
urapidil consumption
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
urapidil consumption on POD1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nan Jiang

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. januar 2016

Primær færdiggørelse (Forventet)

31. december 2017

Studieafslutning (Forventet)

31. december 2017

Datoer for studieregistrering

Først indsendt

6. marts 2017

Først indsendt, der opfyldte QC-kriterier

6. marts 2017

Først opslået (Faktiske)

9. marts 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. marts 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NJiang2016-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

the IPD will not be shared with others, since following investigations based on this trial is about to start.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Anæstesi

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