Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)
25 marzo 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
162
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
- 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
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: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Altri nomi:
intravenous (IV) single bolus dose of 0.6 mg.kg-1
|
|
Sperimentale: 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.
|
Altri nomi:
intravenous (IV) single bolus dose of 0.6 mg.kg-1
|
|
Sperimentale: 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.
|
Altri nomi:
intravenous (IV) single bolus dose of 0.6 mg.kg-1
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
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)
29 dicembre 2005
Completamento primario (Effettivo)
20 ottobre 2006
Completamento dello studio (Effettivo)
20 ottobre 2006
Date di iscrizione allo studio
Primo inviato
15 maggio 2007
Primo inviato che soddisfa i criteri di controllo qualità
15 maggio 2007
Primo Inserito (Stima)
17 maggio 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 aprile 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 marzo 2019
Ultimo verificato
1 marzo 2019
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- P05950 (Altro identificatore: Schering-Plough Study Number)
- 19.4.305 (Altro identificatore: Organon Study Number)
- MK-8616-029 (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 .
Prove cliniche su Sugammadex
-
University Health Network, TorontoMerck Sharp & Dohme LLCCompletatoDecompressione e fusione cervicale posterioreCanada
-
Seoul National University HospitalReclutamentoCurarizzazione residua postoperatoriaCorea, Repubblica di
-
Wake Forest University Health SciencesMerck Sharp & Dohme LLCReclutamentoRitenzione urinaria postoperatoriaStati Uniti
-
Severance HospitalCompletatoPeriodo di recupero dall'anestesia, blocco neuromuscolareCorea, Repubblica di
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletatoCancro alla prostata | Blocco neuromuscolareItalia
-
Merck Sharp & Dohme LLCCompletatoInsufficienza renale | Insufficienza renaleStati Uniti
-
Hopital FochCompletato
-
Beijing Tiantan HospitalCompletatoSugammadex | Potenziali evocati motoriCina
-
Merck Sharp & Dohme LLCCompletato
-
Technical University of MunichCompletatoBlocco neuromuscolareGermania