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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Experimental | Sugammadex |
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| Neostigmine | Active Comparator | Neostigmine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within up to 3 hours after the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Presence of qTOF <0.9 in PACU | Incidence of qTOF <0.9 in PACU | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Fernandez-Bustamante, M.D., Ph.D. | University of Colorado School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41833179 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex | Sugammadex Sugammadex: 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 |
| FG001 | Neostigmine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2020 |
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| 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 |
|
| 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 | Within up to 3 postoperative days |
Neostigmine Neostigmine: 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 |
| COMPLETED | 2 participants in each group lacked sufficient information for primary outcome assessment |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex | Sugammadex Sugammadex: 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 |
| BG001 | Neostigmine | Neostigmine Neostigmine: 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Preoperative hemodialysis | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Within up to 3 hours after the end of surgery |
|
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| ||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Presence of qTOF <0.9 in PACU | Incidence of qTOF <0.9 in PACU | Posted | Count of Participants | Participants | Within up to 3 hours after the end of surgery |
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| |||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | Within up to 3 postoperative days and at 14 +/- 3 days after surgery |
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| |||||||||||||||||||||||||||||||
| Secondary | Rate of Adverse Events Related to NMBR Medications | Adverse events related to NMBR medications, including hypersensitivity and any other adverse events | Posted | Count of Participants | Participants | Within up to 3 postoperative days |
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First 2 postoperative weeks
Following definitions and processes described in protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugammadex | Sugammadex Sugammadex: 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 | 0 | 42 | 4 | 42 | 2 | 42 |
| EG001 | Neostigmine | Neostigmine Neostigmine: 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 | 0 | 42 | 4 | 42 | 1 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative ureteral leak | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Cerebrovascular accident | Vascular disorders | Non-systematic Assessment |
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| Reoperation for bleeding | Vascular disorders | Non-systematic Assessment |
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| Kidney graft dysfunction | Renal and urinary disorders | Non-systematic Assessment |
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| Opioid-induced respiratory depression | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory symptoms requiring oxygen supplementation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ana Fernandez-Bustamante | University of Colorado School of Medicine | 720-848-6744 | ana.fernandez-bustamante@cuanschutz.edu |
| Apr 24, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D055191 | Delayed Emergence from Anesthesia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| Male |
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| Hispanic or Latino |
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| Other |
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