The Neuromuscular Effect of Rocuronium in Patient
14. februar 2016 oppdatert av: Go Eun Bae
The Neuromuscular Effect of Rocuronium in Patient Measuring Muscle Mass by Bioelectrical Impedance Analysis
Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles.
There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction.
The purpose of this study is to find 50% effective dose and 95% effective dose of rocuronium according to muscle mass.
Studieoversikt
Detaljert beskrivelse
Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles.
There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction.
Until now, dose of rocuronium has been judged by patient's weight and height.
When the rocuronium was developed, 50% effective dose and 95% effective dose of rocuronium was calculated by patient corrected body weight which used weight and height.
However, height and weight do not represent exact muscle mass.
The purpose of this study is to find 50% effective dose and 95% effective dose of rocuronium according to muscle mass.
Measurement of muscle mass will be obtained using bioelectrical impedence analysis.
Studietype
Intervensjonell
Registrering (Forventet)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Seoul, Korea, Republikken, 02841
- Rekruttering
- Korea University Anam Hospital
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Ta kontakt med:
- Goeun Bae, M.D.
- Telefonnummer: 8229205632
- E-post: bgecs@naver.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
19 år til 64 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- All patient who undergo general anesthesia
Exclusion Criteria:
- Liver and kidney disease
- Any types of muscle disorder.
- Metal materials or pacemaker in body
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: rocuronium 1
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.24mg per muscle mass(kg).
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Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) after fast for eight hours.
The individual dose method was used for the determination of the dose response of rocuronium.
After induction of anesthesia, four groups of 40 patients each received randomly one of the four doses of rocuronium ( 0.24, 0.32, 0.40, 0.48mg/muscle mass(kg))
Andre navn:
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Eksperimentell: rocuronium 2
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.32mg per muscle mass(kg).
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Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) after fast for eight hours.
The individual dose method was used for the determination of the dose response of rocuronium.
After induction of anesthesia, four groups of 40 patients each received randomly one of the four doses of rocuronium ( 0.24, 0.32, 0.40, 0.48mg/muscle mass(kg))
Andre navn:
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Eksperimentell: rocuronium 3
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.40mg per muscle mass(kg).
|
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) after fast for eight hours.
The individual dose method was used for the determination of the dose response of rocuronium.
After induction of anesthesia, four groups of 40 patients each received randomly one of the four doses of rocuronium ( 0.24, 0.32, 0.40, 0.48mg/muscle mass(kg))
Andre navn:
|
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Eksperimentell: rocuronium 4
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.48mg per muscle mass(kg).
|
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) after fast for eight hours.
The individual dose method was used for the determination of the dose response of rocuronium.
After induction of anesthesia, four groups of 40 patients each received randomly one of the four doses of rocuronium ( 0.24, 0.32, 0.40, 0.48mg/muscle mass(kg))
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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percentage of neuromuscular block
Tidsramme: ten minutes
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percentage of neuromuscular block is calculated by ratio of T1 to T4. T1 is result of first stimulation and T4 is result of fourth stimulation which are obtained by commonly used neuromuscular monitoring device.
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ten minutes
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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onset time
Tidsramme: ten minutes
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time from the end of injection of rocuronium until the maximal depression of T1 which is result of first twitch
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ten minutes
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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lag time
Tidsramme: ten minutes
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time from the end of injection of rocuronium until the first depression of the twitch response
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ten minutes
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Go eun Bae, M.D., Korea University Anam Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2016
Primær fullføring (Forventet)
1. juli 2016
Studiet fullført (Forventet)
1. august 2016
Datoer for studieregistrering
Først innsendt
13. januar 2016
Først innsendt som oppfylte QC-kriteriene
13. januar 2016
Først lagt ut (Anslag)
15. januar 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. februar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. februar 2016
Sist bekreftet
1. februar 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Inbody2
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