Parkland Health & Hospital System
Dallas, Texas, 75390, United States
NCT Number: NCT03904550
This study is intended to be a single-site, prospective, randomized, double-blinded study that intends to enroll a total of 60 patients with severe renal impairment undergoing surgery with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to receive either neostigmine (for reversal of cisatracurium) or sugammadex (for reversal of rocuronium). A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. All patients will be monitored with continuous pulse oximetry postoperatively for 24 hours.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Dallas, Texas, 75390, United States
This will be a prospective, randomized, double-blinded study of surgical patients with severe renal impairment that seeks to address the following:
Specific Aim:
To determine whether rocuronium-induced moderate neuromuscular blockade and reversal with sugammadex achieves recovery of neuromuscular function (TOF ≥ 0.9) faster than reversal of cisatracurium-induced moderate neuromuscular blockade and reversal with neostigmine in patients with severe renal impairment.
Primary Hypothesis:
Patients with severe renal impairment who are reversed with sugammadex after rocuronium will achieve a TOF ≥0.9 within a time frame that is one-third of the time it takes for reversal with neostigmine after cisatracurium.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Maintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate
Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex
Time frame: In the operating room, the amount of time after administration of the reversal syringe to reach recovery of neuromuscular function (TOFR ≥ 90%) assessed up to 30 minutes.
Measure how long it takes to return from a TOF of 2 to a TOF ≥ 0.9.
University of Texas Southwestern Medical Center
Other
Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment
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