drugset / Trial / NCT03519854
Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).
RandomizedParallel-groupDouble-blindTreatment
Summary
This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969; MK-8616) when administered for the reversal of neuromuscular blockade in male participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease). The primary objective of this study is to explore the dose-response relation of sugammadex given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg Esmeron®.
Timeline
- Start
- 2002-12-01
- Primary completion
- 2003-06-01
- Completion
- 2003-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sugammadex | Other / unclassified | 1 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 2 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 4 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 6 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 8 mg/kg | Intravenous |
| Background | Rocuronium | Other / unclassified | 0.6 mg/kg | Intravenous |
Indications
No indication recorded.