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Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)

10. april 2019 opdateret af: Merck Sharp & Dohme LLC

A Multicenter, Randomized, Parallel Group, Comparative, Safety-Assessor Blinded, Phase IIIa Trial in Adult Surgical Subjects Under General Anesthesia at Increased Risk for Pulmonary Complications

The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary disease. All drug administration will be via the intravenous (IV) route.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

86

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;
  • Has been diagnosed with or having a past history of pulmonary disease;
  • Is scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium;
  • Is scheduled for surgery in supine position;
  • Has given written informed consent;

Exclusion Criteria:

  • Is expected to have a difficult intubation due to anatomical malformations;
  • Has known or suspected of having neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
  • Has known or suspected of having a (family) history of malignant hyperthermia;
  • Has known or suspected of having an allergy to narcotics, muscle relaxants or other medications used during surgery;
  • Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
  • Is a female who is pregnant or breast-feeding;
  • Is a female of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence] or using only hormonal contraception as birth control;
  • Has already participated in a sugammadex trial including Protocol 19.4.308;
  • Has participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.308.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Rocuronium + Sugammadex 2.0 mg/kg
After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 2.0 mg/kg.
Medicin: Sugammadex
Sugammadex solution for injection.
Andre navne:
  • Org 25969, MK-8616, Bridion®
Medicin: Rocuronium
Rocuronium bromide solution for injection.
Andre navne:
  • Zemuron®
Eksperimentel: Rocuronium + Sugammadex 4.0 mg/kg
After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 4.0 mg/kg.
Medicin: Sugammadex
Sugammadex solution for injection.
Andre navne:
  • Org 25969, MK-8616, Bridion®
Medicin: Rocuronium
Rocuronium bromide solution for injection.
Andre navne:
  • Zemuron®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease
Tidsramme: Up to 90 minutes
The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.9 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
Up to 90 minutes
Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE)
Tidsramme: Up to 7 days
The percentage of participants experiencing ≥1 AE(s) was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Up to 7 days
Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)
Tidsramme: Up to 7 days
The percentage of participants discontinuing from study treatment due to an AE was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Up to 7 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7 in Participants With or Having a Past History of Pulmonary Disease
Tidsramme: Up to 90 minutes
The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.7 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
Up to 90 minutes
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8 in Participants With or Having a Past History of Pulmonary Disease
Tidsramme: Up to 90 minutes
The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.8 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
Up to 90 minutes
Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
Tidsramme: Up to 6 hours (prior to transfer to the recovery room after extubation)
The level of consciousness prior to transfer to the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation.
Up to 6 hours (prior to transfer to the recovery room after extubation)
Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room
Tidsramme: Up to 6 hours (prior to discharge from the recovery room)
The level of consciousness prior to discharge from the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation.
Up to 6 hours (prior to discharge from the recovery room)
Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
Tidsramme: Up to 6 hours (prior to transfer to the recovery room after extubation)
The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task.
Up to 6 hours (prior to transfer to the recovery room after extubation)
Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room
Tidsramme: Up to 6 hours (prior to discharge from the recovery room)
The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task.
Up to 6 hours (prior to discharge from the recovery room)
General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
Tidsramme: Up to 6 hours (prior to transfer to the recovery room after extubation)
Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician.
Up to 6 hours (prior to transfer to the recovery room after extubation)
General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room
Tidsramme: Up to 6 hours (prior to discharge from the recovery room)
Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician.
Up to 6 hours (prior to discharge from the recovery room)

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)

27. oktober 2005

Primær færdiggørelse (Faktiske)

21. august 2006

Studieafslutning (Faktiske)

9. september 2006

Datoer for studieregistrering

Først indsendt

17. maj 2007

Først indsendt, der opfyldte QC-kriterier

17. maj 2007

Først opslået (Skøn)

21. maj 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P05932 (Anden identifikator: Schering-Plough Protocol Number)
  • 19.4.308 (Anden identifikator: Organon Protocol Number)
  • MK-8616-017 (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 .

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Kliniske forsøg med Sugammadex

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