At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 164 enrolled
Drug / intervention
Sugammadexdrug
Likely dose
Sugammadex 0.6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Sugammadex for Anesthesia, General and Neuromuscular Blockade. Completed, enrolled 164 participants.
Detailed Summary
The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects for registration purposes in China.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia, General, Neuromuscular Blockade
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartJan 2010
Primary CompletionAug 2010
TodayJul 2026
First PostedJan 21, 2009
Enrollment StartJan 1, 2010
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.4 years ago
Interventions
Sugammadexdrug
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.