Phase 4 N=84 Randomized Triple-blind Prevention

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

Kidney Transplant; Complications · Postoperative Residual Curarization · Postoperative Residual Weakness

Bottom Line

View on ClinicalTrials.gov: NCT03923556 ↗

Enrolled (actual)

Serious AEs

9.5%

Results posted

May 2025

Primary outcome: Primary: Number of Patients With Hypoventilation in Post-anesthesia Care Unit (PACU) — 22; 23 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sugammadex (Drug); Neostigmine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Hypoventilation in Post-anesthesia Care Unit (PACU)	22; 23	—
SECONDARY Number of Patients With Presence of qTOF <0.9 in PACU	13; 25	—
SECONDARY Number of Participants With Kidney Graft Dysfunction	2; 4	—
SECONDARY Rate of Adverse Events Related to NMBR Medications	0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

At least 18 years or older
Diagnosed with severe kidney dysfunction (defined by plasma creatinine clearance 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03923556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.