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Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)

25. marts 2019 opdateret af: Merck Sharp & Dohme LLC

A Multicenter, Parallel Group, Comparative, Phase IIIa Trial to Compare the Efficacy, Safety, and Pharmacokinetics of Org 25969 in Elderly Subjects With Adult Subjects

The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

162

Fase

  • Fase 3

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) Class 1 to 3
  • 18 years of age or older
  • Scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium
  • Scheduled for surgery in supine position
  • Given written informed consent

Exclusion Criteria:

  • Participants in whom a difficult intubation is expected due to anatomical malformations
  • Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction
  • Participants known or suspected to have a (family) history of malignant hyperthermia
  • Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medications used during surgery
  • Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and magnesium
  • Female participants who are pregnant or breast-feeding
  • Females participants of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), intrauterine device (IUD), abstinence]
  • Participants who had already participated in a Org 25969 trial including Protocol 19.4.305
  • Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.305

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Participants 18 to 64 years old
Participants to receive an intravenous (IV) single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of second twitch (T2) with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
Medicin: Sugammadex
Andre navne:
  • Org 25969; MK-8616
Medicin: Rocurium
intravenous (IV) single bolus dose of 0.6 mg.kg-1
Eksperimentel: Participants 65 to 74 years old
Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
Medicin: Sugammadex
Andre navne:
  • Org 25969; MK-8616
Medicin: Rocurium
intravenous (IV) single bolus dose of 0.6 mg.kg-1
Eksperimentel: Participants 75 years and older
Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
Medicin: Sugammadex
Andre navne:
  • Org 25969; MK-8616
Medicin: Rocurium
intravenous (IV) single bolus dose of 0.6 mg.kg-1

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9
Tidsramme: up to 10 minutes from start of sugammadex
Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.
up to 10 minutes from start of sugammadex

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7
Tidsramme: up to 10 minutes from start of sugammadex
Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.7. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.
up to 10 minutes from start of sugammadex
Mean Time From Start of Administration of to Recovery of the T4/T1 Ratio to 0.8
Tidsramme: up to 10 minutes from start of sugammadex
Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.8. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.
up to 10 minutes from start of sugammadex
Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation
Tidsramme: Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
Participants level of consciousness was assessed post-extubation and prior to transfer to recovery room. The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation. The number of participants in each of the 3 categories was summarized.
Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
Participants Level of Consciousness Prior to Discharge From Recovery Room
Tidsramme: Prior to Discharge from Recovery Room (up to 24 hours)
Participants level of consciousness was assessed prior to discharge from the recovery room. The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation. The number of participants in each of the 3 categories was summarized.
Prior to Discharge from Recovery Room (up to 24 hours)
Number of Participants With General Muscle Weakness Prior to Transfer to the Recovery Room After Extubation
Tidsramme: Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade post-extubation and prior to transfer to recovery room. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as "yes" or "no" to general muscle weakness. Participants who were not cooperative with the examination were not included in the assessment.
Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
Number of Participants With General Muscle Weakness Prior to Discharge From Recovery Room
Tidsramme: Prior to Discharge from Recovery Room (up to 24 hours)
The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade prior to discharge from the recovery room. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as "yes" or "no" to general muscle weakness. Participants who were not cooperative with the examination were not included in the assessment.
Prior to Discharge from Recovery Room (up to 24 hours)
Number of Participants Who Can Perform a 5 Second Head Lift Prior to Transfer to the Recovery Room After Extubation
Tidsramme: Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
Participants were asked to lift their head off the table while in a supine position post-extubation and prior to transfer to recovery room. The number of participants who could perform the 5 second head lift was summarized. Participants who were not cooperative with the examination were not included in the assessment.
Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
Number of Participants Who Can Perform a 5 Second Head Lift Prior to Discharge From Recovery Room
Tidsramme: Prior to Discharge from Recovery Room (up to 24 hours)
Participants were asked to lift their head off the table while in a supine position just prior to discharge from the recovery room. The number of participants who could perform the 5 second head lift was summarized. Participants who were not cooperative with the examination were not included in the assessment.
Prior to Discharge from Recovery Room (up to 24 hours)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merck Sharp & Dohme LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. december 2005

Primær færdiggørelse (Faktiske)

20. oktober 2006

Studieafslutning (Faktiske)

20. oktober 2006

Datoer for studieregistrering

Først indsendt

15. maj 2007

Først indsendt, der opfyldte QC-kriterier

15. maj 2007

Først opslået (Skøn)

17. maj 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • P05950 (Anden identifikator: Schering-Plough Study Number)
  • 19.4.305 (Anden identifikator: Organon Study Number)
  • MK-8616-029 (Anden identifikator: Merck Protocol Number)

Plan for individuelle deltagerdata (IPD)

Studiedata/dokumenter

  1. CSR synopsis

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Anæstesi, general

Kliniske forsøg med Sugammadex

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United Arab Emirates

Betingelser

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Narkotikainterventioner

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Placeringer

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