A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)
A Multi-Center, Randomized, Open-Label, Prospective Bridging, Parallel Dose-Finding Trial Comparing Efficacy, Safety and Pharmacokinetics of 4 Doses of Org 25969 and Placebo Administered at Reappearance of T2 After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part B: Caucasian Subjects
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Is of American Society of Anesthesiologists (ASA) class 1 - 3;
- Is at least 20 years but under 65 years of age;
- Caucasian participants;
- Is scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia with an anticipated duration of about 1.5-3 hours;
- Has given written informed consent.
Exclusion criteria:
- Participants in whom a difficult intubation because of anatomical malformations was expected;
- Is known or suspected to have neuromuscular disorders impairing neuromuscular blocking (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
- Is known or suspected to have a (family) history of malignant hyperthermia;
- Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
- Is receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
- Females who were pregnant;
- Females of childbearing potential not using birth control or using only oral contraception as birth control;
- Was breast-feeding;
- Has already participated in P05971, or in another trial with sugammadex;
- Has participated in another clinical trial, not preapproved by the Sponsor, within 6 months of entering into P05971.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Rocuronium + Placebo
Etter induksjon av anestesi ble en intubasjonsdose på 0,9 mg/kg rokuronium administrert intravenøst (IV), etterfulgt av vedlikeholdsdoser på 0,1-0,2
mg/kg rokuronium IV om nødvendig.
Ved gjenopptreden av T2 ble en enkelt dose placebo administrert IV.
|
After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arm 1) or 0.1 mg/kg vecuronium (arm 6). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of Placebo IV was administered After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. |
|
Eksperimentell: Rocuronium + 0.5 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2
mg/kg rocuronium IV if necessary.
At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
|
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered
Andre navn:
|
|
Eksperimentell: Rocuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2
mg/kg rocuronium IV if necessary.
At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
|
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered
Andre navn:
|
|
Eksperimentell: Rocuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2
mg/kg rocuronium IV if necessary.
At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
|
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered
Andre navn:
|
|
Eksperimentell: Rocuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2
mg/kg rocuronium IV if necessary.
At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
|
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered
Andre navn:
|
|
Placebo komparator: Vecuronium + Placebo
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03
mg/kg vecuronium IV if necessary.
At reappearance of T2 a single dose of placebo was administered IV.
|
After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arm 1) or 0.1 mg/kg vecuronium (arm 6). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of Placebo IV was administered
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV.
Maintenance doses of 0.02-0.03
mg/kg vecuronium IV could be administered if necessary.
|
|
Eksperimentell: Vecuronium + 0.5 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03
mg/kg vecuronium IV if necessary.
At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
|
After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered
Andre navn:
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV.
Maintenance doses of 0.02-0.03
mg/kg vecuronium IV could be administered if necessary.
|
|
Eksperimentell: Vecuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03
mg/kg vecuronium IV if necessary.
At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
|
After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered
Andre navn:
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV.
Maintenance doses of 0.02-0.03
mg/kg vecuronium IV could be administered if necessary.
|
|
Eksperimentell: Vecuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03
mg/kg vecuronium IV if necessary.
At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
|
After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered
Andre navn:
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV.
Maintenance doses of 0.02-0.03
mg/kg vecuronium IV could be administered if necessary.
|
|
Eksperimentell: Vecuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03
mg/kg vecuronium IV if necessary.
At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
|
After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered
Andre navn:
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV.
Maintenance doses of 0.02-0.03
mg/kg vecuronium IV could be administered if necessary.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Tid fra start av administrering av Sugammadex eller placebo til gjenoppretting av forholdet fjerde rykning/første rykning (T4/T1) til 0,9
Tidsramme: Dag 1: Fra start av sugammadex eller placebo-administrasjon til gjenoppretting av T4/T1-forholdet til 0,9 (opptil 24 timer)
|
Nevromuskulær funksjon ble overvåket ved å bruke repeterende Train-Of-Four (TOF) elektriske stimuleringer til ulnarnerven hvert 15. sekund og vurdere rykningsrespons ved adductor pollicis-muskelen.
T1 og T4 refererer til amplitudene (høydene) til henholdsvis første og fjerde rykninger etter TOF-nervestimulering.
T4/T1-forholdet (uttrykt som en desimal på opptil 1,0) indikerer omfanget av utvinning fra nevromuskulær blokade (NMB).
I denne studien ble twitch-responser registrert inntil T4/T1-forholdet nådde >= 0,9, det minste akseptable forholdet som indikerte utvinning fra NMB.
En raskere tid til gjenoppretting av T4/T1-forholdet til 0,9 indikerer en raskere gjenoppretting fra NMB.
|
Dag 1: Fra start av sugammadex eller placebo-administrasjon til gjenoppretting av T4/T1-forholdet til 0,9 (opptil 24 timer)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Tid fra start av administrering av Sugammadex eller placebo til gjenoppretting av T4/T1-forholdet til 0,7
Tidsramme: Dag 1: Fra start av sugammadex eller placebo-administrasjon til gjenoppretting av T4/T1-forholdet til 0,7 (opptil 24 timer)
|
Nevromuskulær funksjon ble overvåket ved å bruke repeterende TOF-elektriske stimuleringer til ulnarnerven hvert 15. sekund og vurdere rykningsrespons ved adductor pollicis-muskelen.
T1 og T4 refererer til amplitudene (høydene) til henholdsvis første og fjerde rykninger etter TOF-nervestimulering.
T4/T1-forholdet (uttrykt som en desimal på opptil 1,0) indikerer omfanget av utvinning fra NMB.
En raskere tid til gjenoppretting av T4/T1-forholdet til 0,7 indikerer en raskere gjenoppretting fra NMB.
|
Dag 1: Fra start av sugammadex eller placebo-administrasjon til gjenoppretting av T4/T1-forholdet til 0,7 (opptil 24 timer)
|
|
Tid fra start av administrering av Sugammadex eller placebo til gjenoppretting av T4/T1-forholdet til 0,8
Tidsramme: Dag 1: Fra start av sugammadex eller placebo-administrasjon til gjenoppretting av T4/T1-forholdet til 0,8 (opptil 24 timer)
|
Nevromuskulær funksjon ble overvåket ved å bruke repeterende TOF-elektriske stimuleringer til ulnarnerven hvert 15. sekund og vurdere rykningsrespons ved adductor pollicis-muskelen.
T1 og T4 refererer til amplitudene (høydene) til henholdsvis første og fjerde rykninger etter TOF-nervestimulering.
T4/T1-forholdet (uttrykt som en desimal på opptil 1,0) indikerer omfanget av utvinning fra NMB.
En raskere tid til gjenoppretting av T4/T1-forholdet til 0,8 indikerer en raskere gjenoppretting fra NMB.
|
Dag 1: Fra start av sugammadex eller placebo-administrasjon til gjenoppretting av T4/T1-forholdet til 0,8 (opptil 24 timer)
|
Samarbeidspartnere og etterforskere
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Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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 (Faktiske)
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Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystemet
- Kolinerge antagonister
- Kolinerge midler
- Nevromuskulære midler
- Nikotiniske antagonister
- Nevromuskulære ikke-depolariserende midler
- Nevromuskulære blokkeringsmidler
- Rocuronium
- Vekuroniumbromid
Andre studie-ID-numre
- P05971
- 19.4.208B (Annen identifikator: Organon Protocol Number)
- MK-8616-035 (Annen identifikator: Merck Protocol Number)
- 2005-001133-15 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Studiedata/dokumenter
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