Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery
- Conditions
- Kidney Transplant; ComplicationsPostoperative Residual CurarizationPostoperative Residual Weakness
- Interventions
- Registration Number
- NCT03923556
- Lead Sponsor
- University of Colorado, Denver
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sugammadex Sugammadex Sugammadex Neostigmine Neostigmine Neostigmine
- Primary Outcome Measures
Name Time Method Number of Patients With Hypoventilation in Post-anesthesia Care Unit (PACU) Within up to 3 hours after the end of surgery Presence of one or more episodes of hypoventilation in PACU, adjusted to qTOF and other confounders
- Secondary Outcome Measures
Name Time Method Number of Patients With Presence of qTOF <0.9 in PACU Within up to 3 hours after the end of surgery Incidence of qTOF \<0.9 in PACU
Rate of Adverse Events Related to NMBR Medications Within up to 3 postoperative days Adverse events related to NMBR medications, including hypersensitivity and any other adverse events
Number of Participants With Kidney Graft Dysfunction Within up to 3 postoperative days and at 14 +/- 3 days after surgery 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.
Trial Locations
- Locations (1)
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States