Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)(P05775AM1)(COMPLETED)
A Multi-center, Open Label Trial, to Show Efficacy and Safety of 4.0 mg.Kg-1 Sugammadex Administered at a Depth of Neuromuscular Blockade of 1-2 PTC Induced by Rocuronium in Chinese and European ASA I-III Subjects Undergoing Elective Surgery Under Propofol Anesthesia
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using
rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).
For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.
Exclusion Criteria:
-Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the
(family of) study/sponsor staff.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Sugammadex in Caucasian Subjects
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered.
Caucasian subjects living in Europe.
|
After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was to be administered.
Maintenance doses of 0.1-0.2
mg/kg rocuronium intravenous (IV) could have been administered if necessary.
At 1-2 PTC after the last administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was to be administered.
Andre navne:
|
|
Eksperimentel: Sugammadex in Chinese Subjects
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered.
Chinese subjects living in China.
|
After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was to be administered.
Maintenance doses of 0.1-0.2
mg/kg rocuronium intravenous (IV) could have been administered if necessary.
At 1-2 PTC after the last administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was to be administered.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9
Tidsramme: Start of administration of sugammadex to recovery from neuromuscular blockade
|
Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery. Analysis of recovery in Chinese subjects was the primary objective; Caucasian subjects and between-group analyses were secondary. |
Start of administration of sugammadex to recovery from neuromuscular blockade
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7
Tidsramme: Start of administration of sugammadex to recovery from neuromuscular blockade
|
Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle.
The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.
|
Start of administration of sugammadex to recovery from neuromuscular blockade
|
|
Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8
Tidsramme: Start of administration of sugammadex to recovery from neuromuscular blockade
|
Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle.
The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.
|
Start of administration of sugammadex to recovery from neuromuscular blockade
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Yu B, Wang X, Helbo Hansen HS, Huang W-Q, Askeland B, Li S, Ding Z, Abels E, Rietbergen H, Woo T, Pendeville P. Sugammadex 4.0 mg/kg reversal of deep rocuronium-induced neuromuscular blockade: a multicenter study in Chinese and Caucasian patients. J Anesthe Clin Res. 2014;5:408. doi: 10.4172/2155-6148.1000408
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- P05775
- 19.4.335
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