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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Rocuronium + Placebo
Efter induktion af anæstesi blev en intubationsdosis på 0,9 mg/kg rocuronium administreret intravenøst (IV), efterfulgt af vedligeholdelsesdoser på 0,1-0,2
mg/kg rocuronium IV om nødvendigt.
Ved gensynet med T2 blev en enkelt dosis placebo administreret 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. |
|
Eksperimentel: 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 navne:
|
|
Eksperimentel: 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 navne:
|
|
Eksperimentel: 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 navne:
|
|
Eksperimentel: 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 navne:
|
|
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.
|
|
Eksperimentel: 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 navne:
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.
|
|
Eksperimentel: 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 navne:
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.
|
|
Eksperimentel: 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 navne:
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.
|
|
Eksperimentel: 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 navne:
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tid fra start af administration af Sugammadex eller placebo til gendannelse af det fjerde twitch/første twitch (T4/T1) forhold til 0,9
Tidsramme: Dag 1: Fra start af sugammadex eller placebo-administration til genopretning af T4/T1-forholdet til 0,9 (op til 24 timer)
|
Neuromuskulær funktion blev overvåget ved at anvende gentagne Train-Of-Four (TOF) elektriske stimulationer til ulnarerven hvert 15. sekund og vurdere twitch-respons ved adductor pollicis-musklen.
T1 og T4 refererer til amplituderne (højderne) af henholdsvis det første og det fjerde ryk efter TOF-nervestimulering.
T4/T1-forholdet (udtrykt som en decimal på op til 1,0) angiver omfanget af genopretning fra neuromuskulær blokade (NMB).
I denne undersøgelse blev twitch-responser registreret, indtil T4/T1-forholdet nåede >= 0,9, det mindst acceptable forhold, der indikerede genopretning fra NMB.
En hurtigere tid til gendannelse af T4/T1-forholdet til 0,9 indikerer en hurtigere genopretning fra NMB.
|
Dag 1: Fra start af sugammadex eller placebo-administration til genopretning af T4/T1-forholdet til 0,9 (op til 24 timer)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tid fra start af administration af Sugammadex eller placebo til gendannelse af T4/T1-forholdet til 0,7
Tidsramme: Dag 1: Fra start af sugammadex eller placebo-administration til genopretning af T4/T1-forholdet til 0,7 (op til 24 timer)
|
Neuromuskulær funktion blev overvåget ved at anvende gentagne elektriske TOF-stimuleringer til ulnarerven hvert 15. sekund og vurdere twitch-respons ved adductor pollicis-musklen.
T1 og T4 refererer til amplituderne (højderne) af henholdsvis det første og det fjerde ryk efter TOF-nervestimulering.
T4/T1-forholdet (udtrykt som en decimal på op til 1,0) angiver omfanget af gendannelse fra NMB.
En hurtigere tid til gendannelse af T4/T1-forholdet til 0,7 indikerer en hurtigere genopretning fra NMB.
|
Dag 1: Fra start af sugammadex eller placebo-administration til genopretning af T4/T1-forholdet til 0,7 (op til 24 timer)
|
|
Tid fra start af administration af Sugammadex eller placebo til gendannelse af T4/T1-forholdet til 0,8
Tidsramme: Dag 1: Fra start af sugammadex eller placebo-administration til genopretning af T4/T1-forholdet til 0,8 (op til 24 timer)
|
Neuromuskulær funktion blev overvåget ved at anvende gentagne elektriske TOF-stimuleringer til ulnarerven hvert 15. sekund og vurdere twitch-respons ved adductor pollicis-musklen.
T1 og T4 refererer til amplituderne (højderne) af henholdsvis det første og det fjerde ryk efter TOF-nervestimulering.
T4/T1-forholdet (udtrykt som en decimal på op til 1,0) angiver omfanget af gendannelse fra NMB.
En hurtigere tid til gendannelse af T4/T1-forholdet til 0,8 indikerer en hurtigere genopretning fra NMB.
|
Dag 1: Fra start af sugammadex eller placebo-administration til genopretning af T4/T1-forholdet til 0,8 (op til 24 timer)
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Kolinerge antagonister
- Kolinerge midler
- Neuromuskulære midler
- Nikotiniske antagonister
- Neuromuskulære ikke-depolariserende midler
- Neuromuskulære blokerende midler
- Rocuronium
- Vecuroniumbromid
Andre undersøgelses-id-numre
- P05971
- 19.4.208B (Anden identifikator: Organon Protocol Number)
- MK-8616-035 (Anden identifikator: Merck Protocol Number)
- 2005-001133-15 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Studiedata/dokumenter
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