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. dubna 2019 aktualizováno: 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.
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
86
Fáze
- Fáze 3
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
Sugammadex solution for injection.
Ostatní jména:
Rocuronium bromide solution for injection.
Ostatní jména:
|
|
Experimentální: 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.
|
Sugammadex solution for injection.
Ostatní jména:
Rocuronium bromide solution for injection.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
27. října 2005
Primární dokončení (Aktuální)
21. srpna 2006
Dokončení studie (Aktuální)
9. září 2006
Termíny zápisu do studia
První předloženo
17. května 2007
První předloženo, které splnilo kritéria kontroly kvality
17. května 2007
První zveřejněno (Odhad)
21. května 2007
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
12. dubna 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. dubna 2019
Naposledy ověřeno
1. dubna 2019
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- P05932 (Jiný identifikátor: Schering-Plough Protocol Number)
- 19.4.308 (Jiný identifikátor: Organon Protocol Number)
- MK-8616-017 (Jiný identifikátor: Merck Protocol Number)
Plán pro data jednotlivých účastníků (IPD)
Studijní data/dokumenty
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .