Sugammadex Comparative Study
(Phase 3B Protocol No. 334)
Mark H. Zornow, M. D. – Principal Investigator

This clinical study compares the safety and effectiveness of Sugammadex vs. neostigmine/robinol as reversal agents for the muscle relaxant rocuronium.  Muscle relaxants are frequently used during anesthesia and surgery to facilitate tracheal intubation and to keep the patient’s muscles relaxed during the procedure.  Sugammadex is an investigational drug that is not yet approved for use in the United States, and neostigmine is FDA-approved and is routinely used with rocuronium at Oregon Health & Science University.

 

Patients undergoing open abdominal surgery under general anesthesia will be randomized to receive Sugammadex or neostigmine/robinol to reverse the effects of rocuronium when the surgical procedure is completed. Study participants will be carefully monitored in the post-anesthesia care unit as well as the day after surgery and at least seven days post-op for any adverse events.

 

Funding for this study is provided by Organon USA, Inc., a part of Schering-Plough.