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

University of Colorado Denver (CU Denver)

Status and phase

Completed

Phase 4

Conditions

Postoperative Residual Curarization

Kidney Transplant; Complications

Postoperative Residual Weakness

Treatments

Drug: Sugammadex

Drug: Neostigmine

Study type

Interventional

Funder types

Other

Identifiers

NCT03923556

18-2707

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.