Neuromuscular Blockade in Patients With Severe Renal Impairment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment

Conditions
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Neuromuscular Blockade, Renal Impairment

Intervention / Treatment
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* Drug: Cisatracurium + Neostigmine
* Drug: Rocuronium + Sugammadex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single site, randomized, controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cisatracurium + Neostigmine<br>Patients in the cisatracurium/neostigmine group will receive 0.2 mg/kg of cisatracurium for neuromuscular paralysis during induction. Additional cisatracurium will be given to keep the patient at a neuromuscular depth of 1 twitch throughout the surgery until the last 30 minutes, during which the patient will be kept at 2 twitches. | Drug: Cisatracurium + Neostigmine<br>* Maintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate<br>|
| Active Comparator: Rocuronium + Sugammadex<br>Patients in the rocuronium/sugammadex group will receive 0.6 mg/kg of rocuronium for neuromuscular paralysis during induction. Additional rocuronium will be given to keep the patient at a neuromuscular depth of 1 twitch throughout the surgery until the last 30 minutes, during which the patient will be kept at 2 twitches. | Drug: Rocuronium + Sugammadex<br>* Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Until Complete Reversal of Neuromuscular Blockade | Measure how long it takes to return from a TOF of 2 to a TOF ≥ 0.9. | 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. |