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 avril 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
86
Phase
- Phase 3
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
Rocuronium bromide solution for injection.
Autres noms:
|
|
Expérimental: 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.
Autres noms:
Rocuronium bromide solution for injection.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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)
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
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Publications et liens utiles
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Publications générales
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
27 octobre 2005
Achèvement primaire (Réel)
21 août 2006
Achèvement de l'étude (Réel)
9 septembre 2006
Dates d'inscription aux études
Première soumission
17 mai 2007
Première soumission répondant aux critères de contrôle qualité
17 mai 2007
Première publication (Estimation)
21 mai 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 avril 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 avril 2019
Dernière vérification
1 avril 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P05932 (Autre identifiant: Schering-Plough Protocol Number)
- 19.4.308 (Autre identifiant: Organon Protocol Number)
- MK-8616-017 (Autre identifiant: Merck Protocol Number)
Plan pour les données individuelles des participants (IPD)
Données/documents d'étude
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .