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

6. mars 2017 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Forventet)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Dexmedetomidine
Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.
Legemiddel: Dexmedetomidine
1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.
Andre navn:
  • 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.
Annen: normal saline
equal volume of normal saline was administered intravenously constantly after tracheal extubation.
Andre navn:
  • NS

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nan Jiang

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2016

Primær fullføring (Forventet)

31. desember 2017

Studiet fullført (Forventet)

31. desember 2017

Datoer for studieregistrering

Først innsendt

6. mars 2017

Først innsendt som oppfylte QC-kriteriene

6. mars 2017

Først lagt ut (Faktiske)

9. mars 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. mars 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mars 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NJiang2016-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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