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Effects of Dexmedetomidine During Radiofrequency Ablation of Abdominal Tumours

16. december 2014 opdateret af: Egidijus Semenas, Uppsala University Hospital

Effects of Dexmedetomidine on Periprocedural Pain During Radiofrequency Ablation of Liver and Kidney Tumours

The purpose of he study is to evaluate effects of dexmedetomidine on pain during radiofrequency ablation of liver and kidney tumours.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Although radiofrequency ablation (RF) is accepted as the best therapeutic choice for patients with early stage hepatocellular carcinoma when liver transplantation or surgical resection are not suitable options, it is still performed only in a few hospitals and experience is so far limited (Goldberg & Ahmed, 2002; Shiina et al., 2005). In addition, RF ablation is emerging as a viable alternative to surgery for inoperable patients with limited hepatic metastatic disease, especially from colorectal cancer. Although radiofrequency ablation has been accepted as a safe and effective treatment for liver and kidney tumours, there are few studies addressing periprocedural pain.

Thus, the optimal anaesthetic procedure is still to be determined. Currently at our institution RF is performed as monitored sedation procedure using remifentanil infusion supplemented with midazolam boluses, when considered necessary. However, when using remifentanil and midazolam combination it is quite difficult to avoid too deep respiratory depression.

Dexmedetomidine is an α2-adrenoreceptor agonist with sedative, analgesic and anxiolytic effects, and it has more selective α2-adrenergic effect than clonidine. Dexmedetomidine has a great deal of potential in this arena given its analgesic and anxiolytic properties while preserving respiratory drive (Bergese SD et al., 2010).

All patients will receive dexmedetomidine 0.4 µg/kg/hr infusion from the start of procedure. The infusion will be continued during the whole RF procedure.

At the same time all patients will receive remifentanil infusion according to TCI (target controlled infusion) protocol. Plasma concentration target will be set from 0.5 ng/ml and, if necessary, will be increased to achieve a comfortable state of patient (Ramsey Sedation Scale: 2-3).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Sverige
      • Uppsala, Sverige, 75185
        • Uppsala University Hospital

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • liver or/and kidney cancer for which radiofrequency ablation procedure is planned
  • signed informed consent form

Exclusion Criteria:

  • patient refusal
  • pregnancy
  • known allergy to dexmedetomidine or remifentanil
  • atrioventricular block grade II or III or other significant cardiac conduction disturbance
  • stroke
  • low blood pressure not responding to treatment

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dexmedetomidin
Medicin: Dexmedetomidine
Dexmedetomidine 0.4 µg/kg/hr infusion during RF procedure

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Satisfaction With Sedation Technique
Tidsramme: After completion of procedure (within 15 minutes)
Rating of how satisfied the patient was with their sedation on a scale of 1-5 with 1 being very dissatisfied and 5 being extremely satisfied
After completion of procedure (within 15 minutes)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate
Tidsramme: During procedure and up to 2 hours stay at the post-anesthesia care unit
During procedure and up to 2 hours stay at the post-anesthesia care unit
Ramsey Sedation Scale Score
Tidsramme: During the procedure and up to 2 hours stay at the post-anesthesia care unit
Rating of depth of sedation. Scale 1 - 6, 1 being wide awake and 6 being non-responsive
During the procedure and up to 2 hours stay at the post-anesthesia care unit
Maximal pain intensity
Tidsramme: During procedure and up to 2 hours stay at the post-anesthesia care unit
The 11-point Numerical Rating Scale (NRS) to assess periprocedural pain. Scale of 0-10, with 0:no pain and 10: pain as bad as it could be
During procedure and up to 2 hours stay at the post-anesthesia care unit

Samarbejdspartnere og efterforskere

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

Sponsor

Uppsala University Hospital

Efterforskere

  • Ledende efterforsker: Egidijus Semenas, MD, PhD, Uppsala University Hospital, Uppsala, Sweden
  • Ledende efterforsker: Mats Eriksson, MD, PhD, Uppsala University Hospital, Uppsala, Sweden

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

1. december 2013

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

10. december 2013

Først indsendt, der opfyldte QC-kriterier

13. december 2013

Først opslået (Skøn)

20. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. december 2014

Sidst verificeret

1. december 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RF-01
  • 2013/409 (Uppsala Regional Ethics Committee)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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