Sugammadex as Rescue Therapy

PHASE4CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

July 21, 2023

Primary Completion Date

August 2, 2024

Study Completion Date

August 2, 2024

Conditions
Neuromuscular Blockade
Interventions
DRUG

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."

DRUG

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.

Trial Locations (1)

30303

Grady Memorial Hospital, Atlanta

All Listed Sponsors
collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

collaborator

Georgia Clinical & Translational Science Alliance (CTSA)

UNKNOWN

lead

Emory University

OTHER

NCT05661409 - Sugammadex as Rescue Therapy | Biotech Hunter | Biotech Hunter