Reversing Vecuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery

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Condition / disease
Location
Status: Not yet recruiting

A Dose-Finding Study of Amogammadex Sodium for Reversing Vecuronium and Rocuronium-Induced Neuromuscular Blockade

Background context: Amogammadex sodium has completed Phase I-III clinical studies in China for reversal of rocuronium-induced blockade. No clinical studies have yet been conducted for vecuronium-induced blockade. Therefore, this dose-finding study in an Australian population is intended to support further Phase III trials in European and American populations for reversal of both rocuronium- and vecuronium-induced neuromuscular blockade. The goal of this clinical trial is to explore how well different doses of amogammadex sodium work to reverse neuromuscular blockade caused by rocuronium or vecuronium during surgery, and to learn about its safety. The main questions it aims to answer are: * How quickly and effectively does amogammadex sodium restore muscle strength after moderate or deep neuromuscular blockade? * What medical problems do participants have when receiving amogammadex sodium? Researchers will compare different doses of amogammadex sodium to see which works best. All participants will receive amogammadex sodium, but at different dose levels depending on when they join the study. Participants will: * Undergo screening up to 28 days before surgery to confirm eligibility * Receive amogammadex sodium at the end of surgery to reverse the effects of the muscle relaxant * Stay in the study for follow-up visits up to 7 days after surgery.

Participants needed: 64
Trial details
Phase: Phase 2Age: 18-60Biological sex: AllType: InterventionalSponsor: Amckaus PTY LTD.Updated: May 19, 2026
Eligibility criteria

Participants should be willing to participate in the clinical study; the partici... [+9]

Known or expected difficult intubation due to anatomical deformities [+18]