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Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)

18. august 2017 oppdatert av: Merck Sharp & Dohme LLC

A Multi-Center Randomized Safety Assessor-Blinded Placebo-Controlled Parallel and Dose Escalating Dose-Finding Trial in Subjects of ASA 1 - 2 to Assess the Safety, Efficacy and PK of Sugammadex Administered at 5 Min. After Administration of 1.2 mg/kg Esmeron

The purpose of this study is to determine the optimal dose of sugammadex when this compound is administered during deep neuromuscular block. Sugammadex is administered shortly (5 minutes) after administration of a high dose (1.2 mg/kg) of the neuromuscular blocking agent rocuronium . Under these circumstance the neuromuscular block is deep. The safety and pharmacokinetics of sugammadex are also studied.

Studieoversikt

Status

Fullført

Studietype

Intervensjonell

Registrering (Faktiske)

45

Fase

  • Fase 2

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

18 år til 64 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • ASA 1 - 2 between the ages of 18 and 64, inclusive
  • Scheduled for surgical procedures with an anticipated duration of anesthesia of at least 90 minutes, without further need for muscle relaxation other than for intubation
  • Scheduled for surgery in supine position
  • Given written informed consent

Exclusion Criteria:

  • Subjects in whom a difficult intubation because of anatomical malformations was expected
  • Subjects known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction
  • Subjects known or suspected to have a (family) history of malignant hyperthermia
  • Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
  • Subjects receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants and Mg2+
  • Subjects who had already participated in CT 19.4.205
  • Subjects who had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.205
  • Female subjects who are pregnant: in females pregnancy was to be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who were not of childbearing potential i.e. at least 2 years postmenopausal or underwent tubal ligation or an hysterectomy
  • Females of childbearing potential not using an acceptable method of birth control: condom or diaphragm with spermicide, vasectomized partner (>6 months), IUD, abstinence
  • Subjects giving breast-feeding

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: 1
rocuronium + 16.0 mg/kg Org 25969

After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)

At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered

Eksperimentell: 2
rocuronium + 2.0 mg/kg Org 25969

After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)

At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered

Andre navn:
  • Org 25969
Eksperimentell: 3
rocuronium + 4.0 mg/kg Org 25969

After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)

At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered

Andre navn:
  • Org 25969
Eksperimentell: 4
rocuronium + 8.0 mg/kg Org 25969

After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)

At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered

Andre navn:
  • Org 25969
Eksperimentell: 5
rocuronium + 12.0 mg/kg Org 25969

After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)

At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered

Andre navn:
  • Org 25969

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9.
Tidsramme: After administration of rocuronium
After administration of rocuronium

Sekundære resultatmål

Resultatmål
Tidsramme
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.7; Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8.
Tidsramme: After administration of rocuronium
After administration of rocuronium

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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 (Faktiske)

7. november 2003

Primær fullføring (Faktiske)

14. juli 2004

Studiet fullført (Faktiske)

14. juli 2004

Datoer for studieregistrering

Først innsendt

21. september 2006

Først innsendt som oppfylte QC-kriteriene

21. september 2006

Først lagt ut (Anslag)

22. september 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. august 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. august 2017

Sist bekreftet

1. august 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • P05942
  • 19.4.205

Plan for individuelle deltakerdata (IPD)

Studiedata/dokumenter

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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