Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment

STU-2018-0411

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.

2019-12-10

2022-08-11

2023-07-01

Completed

Early phase I

49

Inclusion Criteria: * 18-80 years old * Severe renal impairment (CrCl \< 30 mL/min) * Undergoing non-emergent surgery that requires neuromuscular blockade * Planned extubation in the operating room immediately after surgery * American Society of Anesthesiologists (ASA) physical status classification 3 to 4 * Willing and able to consent in English or Spanish * No personal history of neuromuscular disease Exclusion Criteria: * Age less than 18 or older than 80 * Patient does not speak English or Spanish * Planned postoperative intubation/ventilation * Allergy to sugammadex, neostigmine, glycopyrrolate, cisatracurium, or rocuronium * Family or personal history of malignant hyperthermia * Patient refusal * Pregnant or nursing women * "Stat" (emergent) cases * Pre-existing muscle weakness of any etiology * Patients on toremifene (a selective estrogen receptor modulator) * Women on oral contraceptives who do not wish to use a non-hormonal method of contraception for 7 days following surgery

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2023-11-08