Sugammadex for Postoperative Weakness

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Postoperative Weakness+2 MoreSugammadex - Drug
Eligibility
18 - 90
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing two different medications to see which one works better at reversing muscle paralysis at the end of kidney transplant surgery, in order to reduce weakness and breathing problems after surgery.

Eligible Conditions
  • Postoperative Residual Curarization
  • Postoperative Weakness
  • Transplant Kidney Complication

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 21 Secondary · Reporting Duration: Within up to 3 postoperative days and at 14 +/- 3 days after surgery

During PACU stay
Hospital resources utilization: PACU stay duration
During operating room stay
Duration of anesthesia
Duration of surgery
Hospital resources utilization: total operating room time
Within minutes from NMBR administration intraoperatively
Time from NMBR administration to adequate NMBR
Time from NMBR administration to tracheal extubation
Day 3
Dyspnea functional limitation
Hospital resources utilization: Hospital length of stay
Hospital resources utilization: ICU length of stay
Hospital resources utilization: Rate of ICU admission
Hour 3
Accumulated minutes of hypoventilation in PACU
Hypoventilation
Number of events of hypoventilation in PACU
Presence of qTOF <0.9 in PACU
Within up to 3 postoperative days
Rate of adverse events
Day 3
Kidney graft function as measured by postoperative plasma clearance of creatinine (ClCr)
Number of participants with kidney graft dysfunction
Presence of postoperative pulmonary complications
Within up to 3 postoperative days, counting from PACU discharge
Accumulated minutes of delayed postoperative hypoventilation
Delayed postoperative hypoventilation
Number of events of delayed postoperative hypoventilation
qTOF <0.9 in postoperative floor

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Neostigmine
1 of 2
Sugammadex
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Sugammadex · No Placebo Group · Phase 4

Sugammadex
Drug
Experimental Group · 1 Intervention: Sugammadex · Intervention Types: Drug
Neostigmine
Drug
ActiveComparator Group · 1 Intervention: Neostigmine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sugammadex
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within up to 3 postoperative days and at 14 +/- 3 days after surgery

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,594 Previous Clinical Trials
1,927,296 Total Patients Enrolled
Ana Fernandez-Bustamante, M.D., Ph.D.Principal InvestigatorUniversity of Colorado School of Medicine
1 Previous Clinical Trials
60 Total Patients Enrolled

Eligibility Criteria

Age 18 - 90 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be at least 18 years old to purchase this product.
Diagnosed with a severe kidney dysfunction that results in a creatinine clearance level of less than 30 mL per minute.
I'm planning on a kidney transplant surgery at the University of Colorado Hospital.