- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01871935
Atropine Effects in Anaesthesia With Sufentanil vs. Remifentanil
Comparison of the Effects of Atropine on Haemodynamics and Tissue Oxygenation in Anaesthesia With Propofol and Sufentanil Versus Propofol and Remifentanil
Induction of general anaesthesia with a combination of opiates and hypnotics often induces vasodilation resulting in several haemodynamic effects such as a decrease in blood pressure (MAP), heart rate (HR) and cardiac output (CO). This haemodynamic suppression may jeopardize tissue oxygenation, particularly cerebral oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on the determinants of tissue oxygen delivery as well as on tissue oxygenation. The investigators have demonstrated a significant and clinically relevant increase in CO and cerebral tissue oxygenation (SctO2) for a desired increase in MAP. This is in steep contrast with the more usual clinical practice of administrating classical vasoactive medication such as phenylephrine or norepinephrine, since the two latter have an even negative effect on CO and SctO2. In previous research the investigators used standardized target controlled propofol/remifentanil infusions for induction and maintenance of anaesthesia. It is known that remifentanil has more intense haemodynamic side-effects compared to other opiates such as fentanyl, sufentanil or alfentanil. This raises the question whether the beneficial effect of atropine is restricted to propofol/remifentanil anaesthesia, or if this is equally valid during anaesthesia of propofol combined with other opiates such as sufentanil.
Patients undergoing off-pump coronary artery bypass grafting (CABG) require a long and deep general anaesthesia, which is usually performed with the combination of drugs as mentioned above. Because these patients often experience severe haemodynamic fluctuations they need to be closely monitored.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Groningen, Holland, 9713GZ
- Rekruttering
- University Medical Center Groningen
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Kontakt:
- rob spanjersberg
- E-mail: r.spanjersberg@umcg.nl
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Ledende efterforsker:
- Alain F Kalmar, MD, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age: 18 years and older.
- Elective CABG surgery performed off-pump.
- Written informed consent to participate in this study.
- Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.
Exclusion Criteria:
- Refusal to participate in this study.
- Age: younger than 18 years.
- Pregnant.
- BMI > 35 kg/m2.
- Patients in which atropine is contra-indicated.
- Patients in which sufentanil or remifentanil at the proposed doses are contra-indicated.
- Urgent or emergency surgery.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Remifentanil
Anaesthesia with remifentanil/propofol
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Anaesthesia with remifentanil/propofol.
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Aktiv komparator: Sufentanil
Anaesthesia with sufentanil/propofol
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Anaesthesia with sufentanil/propofol
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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CO
Tidsramme: During anaesthesia
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During anaesthesia
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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MAP
Tidsramme: During anaesthesia
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During anaesthesia
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Tissue oxygen saturation
Tidsramme: During anaesthesia
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During anaesthesia
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CO
Tidsramme: During anaesthesia
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CO obtained by different devices/methods (i.e. the Vigileo device and TEE)
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During anaesthesia
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Alain F Kalmar, MD, PhD, University Medical Center Groningen
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SuRe-002
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Kliniske forsøg med Haemodynamic Fluctuations During Off-pump CABG.
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Population Health Research InstituteCharles University, Czech Republic; Centre hospitalier de l'Université... og andre samarbejdspartnereAfslutteteffektiviteten og sikkerheden af off-pump CABGCanada, Kina, Colombia, Indien, Chile, Argentina, Brasilien, Tjekkiet, Frankrig, Italien, Polen, Kalkun, Det Forenede Kongerige
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