Sugammadex for Reversing Effects of Neuromuscular Blockade – Phase IV

The Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to Less Than 2 Years

Protocol Description

This multi-center study evaluates the effectiveness of sugammadex following a surgical procedure to reverse the effects of a muscle relaxant used during surgery.  Researchers believe that sugammadex, also known by the trade name Bridion™, may be superior to the conventional drug used to reverse moderate neuromuscular blocking as measured by time to neuromuscular recovery.

Study Level: Phase IV

Eligibility Criteria

Subject to certain exclusion criteria, children newborn through ages 2 who require a neuromuscular blocking agent for a non-emergency surgical procedure are eligible for this study.
Boys and Girls: Up to Age 2


Participants will be given a muscle relaxant drug at the beginning of surgery and will receive sugammadex at a specified dosage at the end of the procedure. Blood testing will be done to evaluate how the body processes the study drug on some patients.
Visits: Requires hospitalization for surgery and a follow-up visit and phone call in the post-operative period
Duration: 28 days

Status: Open for Enrollment

Source(s) of Support

Merck Sharp & Dohme

Primary Investigator

Daniela Damian, MD

Contact Information

For more information about the study or enrollment, please contact: 
Denise McCarthy RN, BSN, CRC