Kidney Transplant; ComplicationsPhase 4NCT03923556
Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery
A Phase 4 study testing Sugammadex and Neostigmine in people with Kidney Transplant; Complications and Postoperative Residual Curarization, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Transplant; Complications, Postoperative Residual Curarization, Postoperative Residual Weakness
- What is being tested?
- Sugammadex and Neostigmine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2021to 30 Oct 2023
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
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
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.
Read the 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.
- Conditions
- Kidney Transplant; Complications, Postoperative Residual Curarization, Postoperative Residual Weakness
- Being tested
- Sugammadex, Neostigmine
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Experimental | Sugammadex Receives: Drug: Sugammadex |
| Neostigmine | Active comparator | Neostigmine Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within up to 3 hours after the end of surgery
Secondary outcomes (3)
Number of Patients With Presence of qTOF <0.9 in PACU
Incidence of qTOF <0.9 in PACU
Measured: 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.
Measured: 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
Measured: Within up to 3 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start2 Feb 2021
- Primary completion30 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Fernandez-Bustamante, M.D., Ph.D., Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923556
- Sponsor's protocol ID
- 18-2707
- Status last verified
- May 2025
- First submitted
- 28 Mar 2019
- Last updated
- 22 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stewart E, Kaizer A, Fioravanti J, Russell N, Hendrickse A, Adams M, Pshak T, Fernandez-Bustamante A. Postoperative residual neuromuscular blockade and hypoventilation after rocuronium and sugammadex or neostigmine for kidney transplantation: A randomized clinical trial. J Clin Anesth. 2026 Apr;111:112174. doi: 10.1016/j.jclinane.2026.112174. Epub 2026 Mar 14.
PubMed 41833179