Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep neuromuscular blockaded (induced by rocuronium)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Glycopyrrolate; Neostigmine

Criteria

Inclusion Criteria:

• Patients scheduled for open ventral hernia repair or open colectomy

• ASA class I-III

• 18 years and older

• Subjects with a body mass index (BMI) of <45kg/m2 and weight less than 150kg

• Subjects who have given written informed consent

Exclusion Criteria:

• Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch® SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemaker

• Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)

• Subjects known or suspected to have significant renal dysfunction (e.g. creatinine clearance < 30 mL.min-1

• Subjects known or suspected to have a (family)history of malignant hyperthermia; have significant hepatic dysfunction

• Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other medications used during general anesthesia;

• Subjects known or suspected to be hypersensitive to Sugammadex or other cyclodextrins or Rocuronium or any of its excipients

• Subjects who have a contraindication to, Rocuronium or Sugammadex

• Female subjects who are pregnant

• Morbidly obese subjects with a BMI > 45 kg/m2 or weight more than 150 kg