drugset / Trial / NCT03904550

Neuromuscular Blockade in Patients With Severe Renal Impairment

NCT03904550

Phase 2 Completed 49 enrolled University of Texas Southwestern Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2019-12-10
Primary completion
2022-08-11
Completion
2023-07-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisatracurium Small molecule 0.2 mg/kg
Comparator Neostigmine Other / unclassified
Comparator Rocuronium Other / unclassified 0.6 mg/kg
Comparator Sugammadex Other / unclassified
Comparator Glycopyrrolate Small molecule