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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: Rocuronio + Placebo
Dopo l'induzione dell'anestesia è stata somministrata per via endovenosa (IV) una dose di intubazione di 0,9 mg/kg di rocuronio, seguita da dosi di mantenimento di 0,1-0,2
mg/kg di rocuronio EV se necessario.
Alla ricomparsa di T2 è stata somministrata una singola dose di placebo 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. |
|
Sperimentale: 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
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
|
|
Comparatore placebo: 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.
|
|
Sperimentale: 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
Altri nomi:
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.
|
|
Sperimentale: 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
Altri nomi:
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.
|
|
Sperimentale: 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
Altri nomi:
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.
|
|
Sperimentale: 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
Altri nomi:
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Tempo dall'inizio della somministrazione di Sugammadex o Placebo al recupero del rapporto quarta contrazione/prima contrazione (T4/T1) a 0,9
Lasso di tempo: Giorno 1: dall'inizio della somministrazione di sugammadex o placebo al recupero del rapporto T4/T1 a 0,9 (fino a 24 ore)
|
Il funzionamento neuromuscolare è stato monitorato applicando stimolazioni elettriche ripetitive Train-Of-Four (TOF) al nervo ulnare ogni 15 secondi e valutando la risposta di contrazione del muscolo adduttore del pollice.
T1 e T4 si riferiscono alle ampiezze (altezze) del primo e del quarto spasmo, rispettivamente, dopo la stimolazione del nervo TOF.
Il rapporto T4/T1 (espresso come decimale fino a 1,0) indica l'entità del recupero dal blocco neuromuscolare (NMB).
In questo studio, le risposte di contrazione sono state registrate fino a quando il rapporto T4/T1 ha raggiunto >= 0,9, il rapporto minimo accettabile che indicava il recupero dall'NMB.
Un tempo di recupero più rapido del rapporto T4/T1 a 0,9 indica un recupero più rapido da NMB.
|
Giorno 1: dall'inizio della somministrazione di sugammadex o placebo al recupero del rapporto T4/T1 a 0,9 (fino a 24 ore)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Tempo dall'inizio della somministrazione di Sugammadex o Placebo al recupero del rapporto T4/T1 a 0,7
Lasso di tempo: Giorno 1: dall'inizio della somministrazione di sugammadex o placebo al recupero del rapporto T4/T1 a 0,7 (fino a 24 ore)
|
Il funzionamento neuromuscolare è stato monitorato applicando ripetitive stimolazioni elettriche TOF al nervo ulnare ogni 15 secondi e valutando la risposta di contrazione del muscolo adduttore del pollice.
T1 e T4 si riferiscono alle ampiezze (altezze) del primo e del quarto spasmo, rispettivamente, dopo la stimolazione del nervo TOF.
Il rapporto T4/T1 (espresso come decimale fino a 1,0) indica l'entità del recupero dal NMB.
Un tempo di recupero più rapido del rapporto T4/T1 a 0,7 indica un recupero più rapido da NMB.
|
Giorno 1: dall'inizio della somministrazione di sugammadex o placebo al recupero del rapporto T4/T1 a 0,7 (fino a 24 ore)
|
|
Tempo dall'inizio della somministrazione di Sugammadex o Placebo al recupero del rapporto T4/T1 a 0,8
Lasso di tempo: Giorno 1: dall'inizio della somministrazione di sugammadex o placebo al recupero del rapporto T4/T1 a 0,8 (fino a 24 ore)
|
Il funzionamento neuromuscolare è stato monitorato applicando ripetitive stimolazioni elettriche TOF al nervo ulnare ogni 15 secondi e valutando la risposta di contrazione del muscolo adduttore del pollice.
T1 e T4 si riferiscono alle ampiezze (altezze) del primo e del quarto spasmo, rispettivamente, dopo la stimolazione del nervo TOF.
Il rapporto T4/T1 (espresso come decimale fino a 1,0) indica l'entità del recupero dal NMB.
Un tempo di recupero più rapido del rapporto T4/T1 a 0,8 indica un recupero più rapido da NMB.
|
Giorno 1: dall'inizio della somministrazione di sugammadex o placebo al recupero del rapporto T4/T1 a 0,8 (fino a 24 ore)
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Agenti del sistema nervoso periferico
- Antagonisti colinergici
- Agenti colinergici
- Agenti neuromuscolari
- Antagonisti nicotinici
- Agenti non depolarizzanti neuromuscolari
- Agenti bloccanti neuromuscolari
- Rocuronio
- Bromuro di vecuronio
Altri numeri di identificazione dello studio
- P05971
- 19.4.208B (Altro identificatore: Organon Protocol Number)
- MK-8616-035 (Altro identificatore: Merck Protocol Number)
- 2005-001133-15 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Dati/documenti di studio
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