NCT03904550

Neuromuscular Blockade in Patients With Severe Renal Impairment

Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Neuromuscular Blockade
• Renal Impairment

Interventions

Type	Name	Description
DRUG	Cisatracurium + Neostigmine	Maintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate
DRUG	Rocuronium + Sugammadex	Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex

Timeline

• Start date: 2019-12-10
• Primary completion: 2022-08-11
• Completion: 2023-07-01
• First posted: 2019-04-05
• Last updated: 2023-11-08
• Results posted: 2023-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study