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Completed

NCT Number: NCT03923556

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

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.

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Key information

Conditions

Kidney Transplant; Complications Delayed Emergence from Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Residual Curarization Postoperative Residual Weakness

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sugammadex

Drug

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

Neostigmine

Drug

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

Primary outcomes

  1. Number of Patients With Hypoventilation in Post-anesthesia Care Unit (PACU)

    Time frame: 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 outcomes

  1. Number of Patients With Presence of qTOF <0.9 in PACU

    Time frame: Within up to 3 hours after the end of surgery

    Incidence of qTOF <0.9 in PACU

  2. Number of Participants With Kidney Graft Dysfunction

    Time frame: 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.

  3. Rate of Adverse Events Related to NMBR Medications

    Time frame: Within up to 3 postoperative days

    Adverse events related to NMBR medications, including hypersensitivity and any other adverse events

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2019
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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