Clinical trial NCT03923556: Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery
Official title: A Double-blind, Randomized, Parallel Study to Compare the Efficacy of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery in Patients With Severe Kidney Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant; Complications
Postoperative Residual Curarization
Postoperative Residual Weakness
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients With Hypoventilation in Post-anesthesia Care Unit (PACU)
timeFrame: Within up to 3 hours after the end of surgery
Secondary outcomes:
measure: Number of Patients With Presence of qTOF <0.9 in PACU
timeFrame: Within up to 3 hours after the end of surgery
measure: Number of Participants With Kidney Graft Dysfunction
timeFrame: Within up to 3 postoperative days and at 14 +/- 3 days after surgery
measure: Rate of Adverse Events Related to NMBR Medications
timeFrame: Within up to 3 postoperative days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine
name: Ana Fernandez-Bustamante, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: