- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02097407
Preoperative Dexmedetomidine & EC50 of Propofol (PreopDXM)
Preoperative Dexmedetomidine Reduces the EC50 of Propofol for Successful i-gelTM Insertion Without Muscle Relaxants
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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-
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Seoul, Korea, Republikken, 110-799
- Seoul National University of Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Group D : Dexmedetomidine + propofol group
In Group D, DEX (1 µg kg-1) was intravenously loaded for 10 min before induction of anaesthesia.
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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.
|
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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
EC50 of propofol required for successful i-gel insertion
Tidsramme: During i-gel insertion anticipated up to 1 min
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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.
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During i-gel insertion anticipated up to 1 min
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
the total dose of propofol infused before i-gel insertion
Tidsramme: During i-gel insertion time anticipated upto 1min
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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.
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During i-gel insertion time anticipated upto 1min
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the presence/severity of airway trauma after i-gel insertion
Tidsramme: At the time point of removing the i-gel from patient's mouth
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After removing the i-gel, airway trauma (defined as any blood staining on the device) was recorded.
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At the time point of removing the i-gel from patient's mouth
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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Hee Pyung Park, MD PhD, Professor
- Hovedetterforsker: Young Cheol Kim, Md PhD, Professor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Fysiologiske effekter av legemidler
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Sentralnervesystemdepressiva
- Agenter fra det perifere nervesystemet
- Analgetika
- Sensoriske systemagenter
- Anestesimidler, intravenøst
- Anestesimidler, general
- Bedøvelsesmidler
- Analgetika, ikke-narkotisk
- Adrenerge alfa-2-reseptoragonister
- Adrenerge alfa-agonister
- Adrenerge agonister
- Hypnotika og beroligende midler
- Propofol
- Dexmedetomidin
Andre studie-ID-numre
- PreopDXM_PPF
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