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

6 mars 2017 uppdaterad 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Dexmedetomidine
Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.
Läkemedel: Dexmedetomidine
1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.
Andra namn:
  • DEX
Placebo-jämförare: 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.
Övrig: normal saline
equal volume of normal saline was administered intravenously constantly after tracheal extubation.
Andra namn:
  • NS

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
urapidil consumption
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
urapidil consumption on POD1
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Nan Jiang

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2016

Primärt slutförande (Förväntat)

31 december 2017

Avslutad studie (Förväntat)

31 december 2017

Studieregistreringsdatum

Först inskickad

6 mars 2017

Först inskickad som uppfyllde QC-kriterierna

6 mars 2017

Första postat (Faktisk)

9 mars 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 mars 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 mars 2017

Senast verifierad

1 mars 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NJiang2016-001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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