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Preoperative Dexmedetomidine & EC50 of Propofol (PreopDXM)

24. marts 2014 opdateret af: Hee-Pyoung Park, Seoul National University Hospital

Preoperative Dexmedetomidine Reduces the EC50 of Propofol for Successful i-gelTM Insertion Without Muscle Relaxants

Dexmedetomidine is a useful anaesthetic adjuvant for general anaesthesia. In this prospective randomised study, we determined whether preoperative dexmedetomidine administration could reduce the half maximal effective concentration (EC50) of propofol for successful i-gelTM insertion without muscle relaxants.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Propofol is a useful induction agent for LMA insertion without muscle relaxants because it profoundly inhibits pharyngeal and laryngeal reactivity. A previous report showed that the effect-site concentration of propofol for successful classic LMA insertion in 50% of adults (EC50) without muscle relaxants in healthy male patients was 8.72 (0.55) µg ml-1. The EC50 of propofol may be dependent on the type of LMA used. A previous study comparing the EC50 of the propofol concentration between classic and proseal LMA insertions demonstrated that the EC50 of propofol needed for proseal LMA insertion was 35% greater than that needed for classic LMA insertion. Unfortunately, no investigation has been performed to determine the EC50 of the propofol concentration required for i-gel insertion without muscle relaxants.

Dexmedetomidine (DEX), a selective alpha-2 agonist, has sympatholytic, sedative, and analgesic properties. Such beneficial characteristics make DEX a useful anaesthetic adjuvant for general anaesthesia. Many reports have revealed the beneficial effects of DEX in terms of reducing intraoperative anaesthetic requirements, postoperative analgesic demand, and increased haemodynamic responses to noxious stimuli such as endotracheal intubation. A previous investigation showed that preoperative clonidine, an alpha-2 agonist, decreased the EC50 required for LMA insertion.

We hypothesised that preoperative DEX administration can reduce the propofol concentration required for i-gel insertion. In this study, we compared the EC50 of propofol needed for successful i-gel insertion without muscle relaxants between DEX and placebo groups

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

37

Fase

  • Fase 4

Kontakter og lokationer

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Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 110-799
        • Seoul National University of 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

20 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • ASA physical status I-II patients who were 20-65 years old and scheduled for general anaesthesia for urologic surgery

Exclusion Criteria:

  • Patients with an allergy to alpha-2 adrenergic agonists or propofol
  • Patients who anticipated difficult airway (cervical spinal disease, Mallampati score of III or IV, a mouth opening of <2.5 cm, and/or body mass index of >30 kg m-2), unstable teeth
  • Patients with bradycardia of <50 beats/min, heart block greater than first degree, severe cardiorespiratory dysfunction
  • Patients with symptoms of upper respiratory infection

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group D : Dexmedetomidine + propofol group
In Group D, DEX (1 µg kg-1) was intravenously loaded for 10 min before induction of anaesthesia.
Medicin: Group D : Dexmedetomidine + propofol group

All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of dexmedetomidine. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group D received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min.

After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment.
Placebo komparator: Group C : Saline + propofol group
In Group C, 0.9% of normal saline (1 µg kg-1) was loaded 10 min before induction of anaeshtesia.
Medicin: Group C : Saline + propofol group

All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of normal saline. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group C received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min.

After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
EC50 of propofol required for successful i-gel insertion
Tidsramme: During i-gel insertion anticipated up to 1 min
The EC50 of propofol for successful i-gel insertion was determined by a modification of Dixon's up-and-down method. The response of each patient determined the effect-site propofol concentration for the next patient. If the response was deemed 'successful', the next target concentration of propofol was decreased by 0.5 µg mL-1. If the response was deemed a 'failure', the target concentration was increased by the same dose. The process was repeated until the sixth crossover point (success/failure) was obtained.
During i-gel insertion anticipated up to 1 min

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
the total dose of propofol infused before i-gel insertion
Tidsramme: During i-gel insertion time anticipated upto 1min
The total amount of propofol infused before i-gel insertion was noted. The insertion time, defined as the time from picking up the i-gel until the initiation of mechanical ventilation.
During i-gel insertion time anticipated upto 1min
the presence/severity of airway trauma after i-gel insertion
Tidsramme: At the time point of removing the i-gel from patient's mouth
After removing the i-gel, airway trauma (defined as any blood staining on the device) was recorded.
At the time point of removing the i-gel from patient's mouth

Samarbejdspartnere og efterforskere

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

Sponsor

Seoul National University Hospital

Efterforskere

  • Studieleder: Hee Pyung Park, MD PhD, PROFESSOR
  • Ledende efterforsker: Young Cheol Kim, Md PhD, PROFESSOR

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. maj 2012

Primær færdiggørelse (Faktiske)

1. august 2012

Studieafslutning (Faktiske)

1. august 2012

Datoer for studieregistrering

Først indsendt

24. marts 2014

Først indsendt, der opfyldte QC-kriterier

24. marts 2014

Først opslået (Skøn)

27. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. marts 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. marts 2014

Sidst verificeret

1. marts 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PreopDXM_PPF

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Kliniske forsøg med Urologisk kirurgi

Kliniske forsøg med Group D : Dexmedetomidine + propofol group

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