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Selective Relaxant Binding Agent

Sugammadex vs Neostigmine for Postoperative Weakness After Kidney Transplant

Phase 4
Recruiting
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

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.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~during pacu stay
This trial's timeline: 3 weeks for screening, Varies for treatment, and during pacu stay for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hypoventilation
Secondary outcome measures
Accumulated minutes of delayed postoperative hypoventilation
Accumulated minutes of hypoventilation in PACU
Delayed postoperative hypoventilation
+18 more

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
1,732 Previous Clinical Trials
2,143,483 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

Sugammadex (Selective Relaxant Binding Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03923556 — Phase 4
Residual Curarization Research Study Groups: Neostigmine, Sugammadex
Residual Curarization Clinical Trial 2023: Sugammadex Highlights & Side Effects. Trial Name: NCT03923556 — Phase 4
Sugammadex (Selective Relaxant Binding Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03923556 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards have been identified for individuals taking Sugammadex?

"Due to it being a Phase 4 trial, Sugammadex has already been approved and thus is marked with the highest safety rating of 3."

Answered by AI

What are Sugammadex's primary therapeutical applications?

"Sugammadex is the most typical treatment for neuromuscular blockade, though it may be employed to address post-operative intestinal atony, denture retention, and myasthenia gravis as well."

Answered by AI

Are enrollees still being taken in for this research endeavor?

"Current information found on clinicaltrials.gov confirms that this trial is actively seeking enrolment, having been first posted on February 2nd 2021 and last updated on October 17th 2022."

Answered by AI

Are there any additional experiments concerning Sugammadex that have been completed?

"Currently, there are 15 studies analyzing the efficacy of Sugammadex with 1 trial at Phase 3. The initial trials for this drug commenced in Rochester, Minnesota but now 51 different sites offer it as part of their clinical trials."

Answered by AI

Does this study permit participants aged under 20 years old?

"This trial is seeking volunteers that are over 18 years of age and younger than 90."

Answered by AI

What are the eligibility criteria for participating in this trial?

"This study is seeking 100 volunteers aged between 18 and 90 who have had postoperative residual curarization, with the intention of undergoing kidney transplantation surgery at the University of Colorado Hospital. To be considered for enrolment in this experiment, recipients must satisfy all age requirements (18 or older)."

Answered by AI

How many individuals are contributing to this clinical experiment?

"Affirmative, clinicaltrials.gov's information attests to the fact that this medical trial is currently enrolling participants. It was launched on February 2nd 2021 with a recent update done in October 17th 2022 and it seeks 100 patients from one location."

Answered by AI
~24 spots leftby Apr 2025