Your session is about to expire
← Back to Search
Selective Relaxant Binding Agent
Sugammadex vs Neostigmine for Postoperative Weakness After Kidney Transplant
Phase 4
Waitlist Available
Led By Ana Fernandez-Bustamante, M.D., Ph.D.
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within up to 3 hours after the end of surgery
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions
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.
Who is the study for?
This trial is for adults over 18 with severe kidney dysfunction awaiting a transplant at the University of Colorado Hospital. It's not suitable for those dependent on oxygen or ventilators, have diseases severely limiting breathing, can't consent, are pregnant, or have a BMI over 40 kg/m2.
What is being tested?
The study compares Sugammadex and Neostigmine to see which better reverses muscle paralysis after kidney transplant surgery. The goal is to minimize post-surgery muscle weakness and improve breathing recovery.
What are the potential side effects?
Possible side effects include allergic reactions, changes in heart rate or blood pressure, nausea, vomiting, headache and feelings of general discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during operating room stay
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during operating room stay
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hypoventilation
Secondary study objectives
Accumulated minutes of delayed postoperative hypoventilation
Accumulated minutes of hypoventilation in PACU
Delayed postoperative hypoventilation
+18 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SugammadexExperimental Treatment1 Intervention
Sugammadex
Group II: NeostigmineActive Control1 Intervention
Neostigmine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sugammadex
FDA approved
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,272 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a lung, muscle, or other condition that greatly limits your ability to breathe properly and perform physical activities, such as climbing stairs.You are pregnant.Your body weight is very high and your BMI is above 40.
Research Study Groups:
This trial has the following groups:- Group 1: Neostigmine
- Group 2: Sugammadex
Awards:
This trial has 5 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger