Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery
Study Details
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 |
|---|---|---|
| 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
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
- Hypoventilation in post-anesthesia care unit (PACU) [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
- Time from NMBR administration to adequate NMBR [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 [Within minutes from NMBR administration intraoperatively]
Intraoperative minutes from NMBR administration to tracheal extubation
- Duration of surgery [During operating room stay]
Intraoperative minutes from surgical incision to closure (duration of surgery)
- Duration of anesthesia [During operating room stay]
Intraoperative minutes from tracheal intubation to tracheal extubation (duration of anesthesia)
- Presence of qTOF <0.9 in PACU [Within up to 3 hours after the end of surgery]
Incidence of qTOF <0.9 in PACU
- Number of events of hypoventilation in PACU [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 [Within up to 3 hours after the end of surgery]
Accumulated minutes of hypoventilation in PACU
- Delayed postoperative hypoventilation [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 [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 [Within up to 3 postoperative days, counting from PACU discharge]
Accumulated minutes of hypoventilation in the postoperative floor
- qTOF <0.9 in postoperative floor [Within up to 3 postoperative days, counting from PACU discharge]
Delayed detection of qTOF <0.9 in postoperative floor
- Presence of postoperative pulmonary complications [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 [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) [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 [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 [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 [During operating room stay]
Hospital resources utilization parameters, including total operating room time
- Hospital resources utilization: PACU stay duration [During PACU stay]
Hospital resources utilization parameters, including total PACU stay duration
- Hospital resources utilization: Hospital length of stay [Within up to 14 +/- 3 days after surgery]
Hospital resources utilization parameters, including total hospital stay duration
- Hospital resources utilization: Rate of ICU admission [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 [Within up to 14 +/- 3 days after surgery]
Hospital resources utilization parameters, including total ICU stay duration
Eligibility Criteria
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
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Pregnant women
-
Body Mass Index (BMI) > 40 kg/m2
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Pre-existing oxygen or ventilatory dependency (24h use of oxygen or other noninvasive or invasive ventilatory support)
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
Investigators
- Principal Investigator: Ana Fernandez-Bustamante, M.D., Ph.D., University of Colorado School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18-2707