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出境医 / 临床实验 / Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery

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

Study Description
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.
Study Design
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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
Actual Study Start Date : February 2, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : September 30, 2023
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
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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.
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE March 28, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date February 12, 2021
Actual Study Start Date  ICMJE February 2, 2021
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2020) 		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
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • 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
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
  • 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
  • Time from NMBR administration to tracheal extubation [ Time Frame: Within minutes from NMBR administration intraoperatively ]
    Intraoperative minutes from NMBR administration to tracheal extubation
  • Duration of surgery [ Time Frame: During operating room stay ]
    Intraoperative minutes from surgical incision to closure (duration of surgery)
  • Duration of anesthesia [ Time Frame: During operating room stay ]
    Intraoperative minutes from tracheal intubation to tracheal extubation (duration of anesthesia)
  • 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
  • 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
  • Accumulated minutes of hypoventilation in PACU [ Time Frame: Within up to 3 hours after the end of surgery ]
    Accumulated minutes of hypoventilation in PACU
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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)
  • 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
  • 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.
  • 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
  • Hospital resources utilization: total operating room time [ Time Frame: During operating room stay ]
    Hospital resources utilization parameters, including total operating room time
  • Hospital resources utilization: PACU stay duration [ Time Frame: During PACU stay ]
    Hospital resources utilization parameters, including total PACU stay duration
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • 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
  • Time from NMBR administration to tracheal extubation [ Time Frame: Within minutes from NMBR administration intraoperatively ]
    Intraoperative minutes from NMBR administration to tracheal extubation
  • Duration of surgery and anesthesia [ Time Frame: During operating room stay ]
    Intraoperative minutes from surgical incision to closure (duration of surgery) and from tracheal intubation to tracheal extubation (duration of anesthesia)
  • 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
  • Accumulated minutes of hypoventilation in PACU [ Time Frame: Within up to 3 hours after the end of surgery ]
    Accumulated minutes of hypoventilation in PACU
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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)
  • 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
  • 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.
  • 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
  • Hospital resources utilization: total operating room time [ Time Frame: During operating room stay ]
    Hospital resources utilization parameters, including total operating room time
  • Hospital resources utilization: PACU stay duration [ Time Frame: During PACU stay ]
    Hospital resources utilization parameters, including total PACU stay duration
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Kidney Transplant; Complications
  • Postoperative Residual Curarization
  • Postoperative Residual Weakness
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Sugammadex
    Sugammadex
    Intervention: Drug: Sugammadex
  • Active Comparator: Neostigmine
    Neostigmine
    Intervention: Drug: Neostigmine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ana Fernandez-Bustamante, M.D., Ph.D. 303-724-2935 ana.fernandez-bustamante@cuanschutz.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923556
Other Study ID Numbers  ICMJE 18-2707
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ana Fernandez-Bustamante, M.D., Ph.D. University of Colorado School of Medicine
PRS Account University of Colorado, Denver
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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