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

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ClinicalTrials.gov Identifier: NCT03923556
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Kidney Transplant; Complications Postoperative Residual Curarization Postoperative Residual Weakness Drug: Sugammadex Drug: Neostigmine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
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
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sugammadex
Sugammadex
Drug: Sugammadex
Administration of Sugammadex 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

Active Comparator: Neostigmine
Neostigmine
Drug: Neostigmine
Administration of Neostigmine 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Time from NMBR administration to adequate NMBR [ Time Frame: Within minutes from NMBR administration intraoperatively ]
    Intraoperative minutes from NMBR administration to qTOF T4/T1 equal or greater than 0.9

  2. Time from NMBR administration to tracheal extubation [ Time Frame: Within minutes from NMBR administration intraoperatively ]
    Intraoperative minutes from NMBR administration to tracheal extubation

  3. Duration of surgery [ Time Frame: During operating room stay ]
    Intraoperative minutes from surgical incision to closure (duration of surgery)

  4. Duration of anesthesia [ Time Frame: During operating room stay ]
    Intraoperative minutes from tracheal intubation to tracheal extubation (duration of anesthesia)

  5. 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

  6. Number of events of hypoventilation in PACU [ Time Frame: Within up to 3 hours after the end of surgery ]
    Number of events of hypoventilation lasting 1 minute or longer in PACU

  7. Accumulated minutes of hypoventilation in PACU [ Time Frame: Within up to 3 hours after the end of surgery ]
    Accumulated minutes of hypoventilation in PACU

  8. Delayed postoperative hypoventilation [ Time Frame: Within up to 3 postoperative days, counting from PACU discharge ]
    Presence of one or more episodes of hypoventilation in postoperative floor, adjusted to qTOF and other confounders

  9. Number of events of delayed postoperative hypoventilation [ Time Frame: Within up to 3 postoperative days, counting from PACU discharge ]
    Number of events of hypoventilation lasting 1 minute or longer in the postoperative floor

  10. Accumulated minutes of delayed postoperative hypoventilation [ Time Frame: Within up to 3 postoperative days, counting from PACU discharge ]
    Accumulated minutes of hypoventilation in the postoperative floor

  11. qTOF <0.9 in postoperative floor [ Time Frame: Within up to 3 postoperative days, counting from PACU discharge ]
    Delayed detection of qTOF <0.9 in postoperative floor

  12. Presence of postoperative pulmonary complications [ Time Frame: Within up to 3 postoperative days and at 14 +/- 3 days after surgery ]
    Presence of predefined postoperative pulmonary complications, including respiratory failure, reintubation, ARDS, pneumonia, pneumothorax, atelectasis, pleural effusion or bronchospasm.

  13. Dyspnea functional limitation [ Time Frame: Within up to 14 +/- 3 days after surgery ]
    Score on standardized Patient-Reported Outcomes Measurement Information System (Promis) dyspnea functional limitation questionnaire score, compared to patient's baseline. Functional measurements include walking, lifting and activities of daily living. The higher the score on this instrument the more functional limitation (scale range is from 0 to 30)

  14. Kidney graft function as measured by postoperative plasma clearance of creatinine (ClCr) [ Time Frame: Within up to 3 postoperative days and at 14 +/- 3 days after surgery ]
    Predefined kidney graft function based on postoperative ClCr

  15. 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.

  16. Rate of adverse events [ Time Frame: Within up to 3 postoperative days ]
    Adverse events related to NMBR medications, including hypersensitivity and any other adverse events

  17. Hospital resources utilization: total operating room time [ Time Frame: During operating room stay ]
    Hospital resources utilization parameters, including total operating room time

  18. Hospital resources utilization: PACU stay duration [ Time Frame: During PACU stay ]
    Hospital resources utilization parameters, including total PACU stay duration

  19. Hospital resources utilization: Hospital length of stay [ Time Frame: Within up to 14 +/- 3 days after surgery ]
    Hospital resources utilization parameters, including total hospital stay duration

  20. Hospital resources utilization: Rate of ICU admission [ Time Frame: Within up to 14 +/- 3 days after surgery ]
    Hospital resources utilization parameters, including the need of ICU admission

  21. Hospital resources utilization: ICU length of stay [ Time Frame: Within up to 14 +/- 3 days after surgery ]
    Hospital resources utilization parameters, including total ICU stay duration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923556


Contacts
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Contact: Ana Fernandez-Bustamante, M.D., Ph.D. 303-724-2935 ana.fernandez-bustamante@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Ana Fernandez-Bustamante, MD, PhD    303-724-2935      
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Ana Fernandez-Bustamante, M.D., Ph.D. University of Colorado School of Medicine
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03923556    
Other Study ID Numbers: 18-2707
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents