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)
keskiviikko 10. huhtikuuta 2019 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
86
Vaihe
- Vaihe 3
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
Muut nimet:
Rocuronium bromide solution for injection.
Muut nimet:
|
|
Kokeellinen: 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.
Muut nimet:
Rocuronium bromide solution for injection.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Torstai 27. lokakuuta 2005
Ensisijainen valmistuminen (Todellinen)
Maanantai 21. elokuuta 2006
Opintojen valmistuminen (Todellinen)
Lauantai 9. syyskuuta 2006
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 17. toukokuuta 2007
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 17. toukokuuta 2007
Ensimmäinen Lähetetty (Arvio)
Maanantai 21. toukokuuta 2007
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 12. huhtikuuta 2019
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 10. huhtikuuta 2019
Viimeksi vahvistettu
Maanantai 1. huhtikuuta 2019
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- P05932 (Muu tunniste: Schering-Plough Protocol Number)
- 19.4.308 (Muu tunniste: Organon Protocol Number)
- MK-8616-017 (Muu tunniste: Merck Protocol Number)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Tutkimustiedot/asiakirjat
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Sugammadex
-
University Health Network, TorontoMerck Sharp & Dohme LLCValmisPosterior kohdunkaulan dekompressio ja fuusioKanada
-
Seoul National University HospitalRekrytointiLeikkauksen jälkeinen jäännöskurarisointiKorean tasavalta
-
Wake Forest University Health SciencesMerck Sharp & Dohme LLCRekrytointiLeikkauksen jälkeinen virtsanpidätysYhdysvallat
-
Severance HospitalValmisAnestesian toipumisjakso, neuromuskulaarinen salpausKorean tasavalta
-
Merck Sharp & Dohme LLCValmisMunuaisten vajaatoiminta | Munuaisten vajaatoimintaYhdysvallat
-
Hopital FochValmis
-
Beijing Tiantan HospitalValmisSugammadex | Moottorin herättämät mahdollisuudetKiina
-
Merck Sharp & Dohme LLCValmis
-
Technical University of MunichValmisNeuromuskulaarinen salpausSaksa
-
Yale UniversityMerck Sharp & Dohme LLCValmisSepelvaltimon ohitusleikkaus ja/tai aorttaläpän korvausleikkausYhdysvallat