Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)
25 mars 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
162
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
- 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
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: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Autres noms:
intravenous (IV) single bolus dose of 0.6 mg.kg-1
|
|
Expérimental: 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.
|
Autres noms:
intravenous (IV) single bolus dose of 0.6 mg.kg-1
|
|
Expérimental: 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.
|
Autres noms:
intravenous (IV) single bolus dose of 0.6 mg.kg-1
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
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Publications et liens utiles
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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)
29 décembre 2005
Achèvement primaire (Réel)
20 octobre 2006
Achèvement de l'étude (Réel)
20 octobre 2006
Dates d'inscription aux études
Première soumission
15 mai 2007
Première soumission répondant aux critères de contrôle qualité
15 mai 2007
Première publication (Estimation)
17 mai 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 avril 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 mars 2019
Dernière vérification
1 mars 2019
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- P05950 (Autre identifiant: Schering-Plough Study Number)
- 19.4.305 (Autre identifiant: Organon Study Number)
- MK-8616-029 (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 .