Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery

University of Colorado, Denver84 enrolled

Overview

The purpose of this study is to compare two medications that reverse muscle paralysis at the end of kidney transplant surgery with the goal of reducing residual muscle weakness and insufficient respiratory function after surgery.

This is a prospective randomized double-blind single center study on patients with severe kidney failure undergoing kidney transplantation surgery. Patients will have their muscles paralyzed during general anesthesia for surgery. At the end of surgery, muscle paralysis will be reversed with either neostigmine (control group) or sugammadex (intervention group). Residual muscle weakness and respiratory function will be monitored after surgery with a quantitative train-of-four (qTOF) monitor and a noninvasive continuous ventilation monitor. The investigators hypothesize that patients receiving sugammadex will have less residual muscle weakness and better respiratory function than patients receiving neostigmine. Respiratory and kidney function parameters and any adverse events will be collected during the hospital stay. Patients will contacted for a study follow up around 2 weeks after their surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Kidney Transplant; Complications Postoperative Residual Curarization Postoperative Residual Weakness

Interventions

SugammadexDRUG

Administration of Sugammadex intravenously at a dose appropriate for the reversal of neuromuscular blockade (usually 2-4 mg/kg) at the end of the surgery before tracheal extubation

NeostigmineDRUG

Administration of Neostigmine intravenously at a dose appropriate for the reversal of neuromuscular blockade (usually 0.03-0.07 mg/kg) at the end of the surgery before tracheal extubation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 18 years or older * Diagnosed with severe kidney dysfunction (defined by plasma creatinine clearance \<30 mL/min) * Planning on kidney transplantation surgery at the University of Colorado Hospital. Exclusion Criteria: * Patients unable to sign the informed consent * Pregnant women * Body Mass Index (BMI) \> 40 kg/m2 * Pre-existing oxygen or ventilatory dependency (24h use of oxygen or other noninvasive or invasive ventilatory support) * Patients with any pulmonary, neuromuscular or other disease that severely limits their respiratory functional status (e.g. unable to achieve 4 Metabolic Equivalent of Tasks, METs, such as climbing up 1 flight of stairs) * Presence of any contraindication for any of the study-related medications or interventions.

Locations (1)

University of Colorado Hospital

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Number of Patients With Hypoventilation in Post-anesthesia Care Unit (PACU)

Presence of one or more episodes of hypoventilation in PACU, adjusted to qTOF and other confounders

Time frame: Within up to 3 hours after the end of surgery

Secondary Outcomes

Number of Patients With Presence of qTOF <0.9 in PACU

Incidence of qTOF \<0.9 in PACU

Time frame: Within up to 3 hours after the end of surgery

Number of Participants With Kidney Graft Dysfunction

Predefined kidney graft negative outcomes including: postoperative increasing ClCr, reduced daily urine output, need for dialysis postoperatively, and/or diagnosis of delayed graft function or kidney graft rejection.

Time frame: Within up to 3 postoperative days and at 14 +/- 3 days after surgery

Rate of Adverse Events Related to NMBR Medications

Adverse events related to NMBR medications, including hypersensitivity and any other adverse events

Time frame: Within up to 3 postoperative days

Data from ClinicalTrials.gov

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