Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram
12. august 2012 opdateret af: Wei Mei, Huazhong University of Science and Technology
Sevoflurane can abolish movement or adrenergic response to noxious stimulus.
In order to investigate the effect of sevoflurane on cerebral electrical activity, we determined the MAC of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie) in middle aged subjects.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients received sevoflurane for anesthesia induction and maintenance at preselected concentrations according to an 'up and down' design, with 0.2% as a stepsize.
General anesthesia was induced and maintained with sevoflurane, tracheal intubation was facilitated with cisatracurium.
After a steady-state period of 30min without surgical stimulation, the state of isoelectric EEG was considered as significant when a burst suppression ratio of 100% last for more than 1 min.
The haemodynamic responses to skin incision and the vasopressor requirement to maintain cardiovascular system were also analysed according to the EEG state.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
31
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Hubei
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Wuhan, Hubei, Kina, 430030
- Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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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
45 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 45-65yr
- upper abdominal surgery in general anaesthesia
- ASA physical status classification of I or II
Exclusion Criteria:
- neurological disease
- received central nervous system-active drugs
- cardiac ejection fraction less than 40%
- history of difficult intubation or anticipated difficult intubation
- daily alcohol consumption
- obesity, defined as a body-mass index of more than 30
- without informed consent
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 |
|---|---|
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Eksperimentel: Sevoflurane
Anaesthesia was induced by 8% sevoflurane.
Cisatracurium 0.15mg kg-1 was administered after loss of the lash reflex, then ventilated manually until the amplitude of T1 decreased to 0. Intubation was performed and switched to mechanical ventilation with a fresh gas flow 2L min-1.
Gas concentrations were analysed using a gas analyser.The end-tidal concentration of carbon dioxide was maintained at 4.7kPa; an esophageal temperature probe was inserted and a warming unit was used if necessary to maintain normothermia (35.5°-38.5°).
The surgical incision was performed at least 30min after tracheal intubation.
When arterial blood pressure (MAP) decrease exceeding 20% of baseline values.
Phenylephrine 0.1mg was administered intravenously if necessary to maintained MAP and recorded.
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The design of experiment is referred to the "Dixon up-and-down" method.
The first subject was designed to receive end-tidal sevoflurane concentration of 1.7%.
For each subject, 30 min interval time was given.
The isoelectric EEG was considered as significant when the isoelectric state last for more than 1min.
The maximal burst suppression rate was recorded if isoelectric EEG was not reached.
Heart rate and MAP, were recorded 2 and 1min before and 3 min after skin incision.
Adrenergic reflexes positive cases were counted.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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MACie
Tidsramme: 30min
|
Minimal Alveolar Concentration of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)
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30min
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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MACbs
Tidsramme: 30 min
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Minimal Alveolar Concentration of sevoflurane inducing inducing burst suppression EEG (MACbs) in middle aged adults.
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30 min
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Hemodynamic parameters
Tidsramme: 3 min
|
Hemodynamic parameters 2 min before and 3 min after skin incision
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3 min
|
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Use of phenylephrine
Tidsramme: 30 min
|
Use of phenylephrine during induction and maintenance of anesthesia with sevoflurane.
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30 min
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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. marts 2012
Primær færdiggørelse (Faktiske)
1. maj 2012
Studieafslutning (Faktiske)
1. juli 2012
Datoer for studieregistrering
Først indsendt
8. august 2012
Først indsendt, der opfyldte QC-kriterier
9. august 2012
Først opslået (Skøn)
10. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. august 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. august 2012
Sidst verificeret
1. august 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TJMZK20120301
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