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 aprile 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
86
Fase
- Fase 3
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
Rocuronium bromide solution for injection.
Altri nomi:
|
|
Sperimentale: 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.
Altri nomi:
Rocuronium bromide solution for injection.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
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Pubblicazioni generali
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
27 ottobre 2005
Completamento primario (Effettivo)
21 agosto 2006
Completamento dello studio (Effettivo)
9 settembre 2006
Date di iscrizione allo studio
Primo inviato
17 maggio 2007
Primo inviato che soddisfa i criteri di controllo qualità
17 maggio 2007
Primo Inserito (Stima)
21 maggio 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 aprile 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 aprile 2019
Ultimo verificato
1 aprile 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P05932 (Altro identificatore: Schering-Plough Protocol Number)
- 19.4.308 (Altro identificatore: Organon Protocol Number)
- MK-8616-017 (Altro identificatore: Merck Protocol Number)
Piano per i dati dei singoli partecipanti (IPD)
Dati/documenti di studio
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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