46
Participants
Start Date
July 21, 2023
Primary Completion Date
August 2, 2024
Study Completion Date
August 2, 2024
Sugammadex
"Sugammadex is a FDA-approved drug that is in routine clinical use for NMB reversal.~Patients will be randomized to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated."
Placebo
Normal saline will be used as placebo. The inclusion of a placebo group would allow us to examine if patients may recover spontaneously over that time without needing any sugammadex at all, and what parameters may predict that subset of patients. It will also improve the dose response modelling, in that randomization has been weighted so that patients who are least likely to need sugammadex (i.e. if they achieved a TOF count of 4 twitches without fade) are more likely to be in the placebo group or at the lowest dose of sugammadex that is being tested.
Grady Memorial Hospital, Atlanta
National Center for Advancing Translational Sciences (NCATS)
NIH
Georgia Clinical & Translational Science Alliance (CTSA)
UNKNOWN
Emory University
OTHER