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Selective Relaxant Binding Agent
Sugammadex for Postoperative Urinary Retention
Phase 1 & 2
Recruiting
Led By Omar Duenas Garcia, MD
Research Sponsored by West Virginia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female patients undergoing a vaginal hysterectomy with the indications of pelvic organ prolapse or abnormal uterine bleeding
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 hours postop
Awards & highlights
Study Summary
This trial will compare two anesthetic drugs to see which is more effective for hysterectomy surgery under general anesthesia.
Who is the study for?
This trial is for female patients having a vaginal hysterectomy due to pelvic organ prolapse or abnormal bleeding. It excludes those with voiding issues, severe kidney problems, risk of malignant hyperthermia, allergies to study drugs or anesthesia meds, recent participation in other trials, pregnancy, and certain surgical approaches.Check my eligibility
What is being tested?
The study tests Sugammadex against a standard glycopyrrolate/neostigmine combo during surgery under general anesthesia. It's randomized and double-blinded; neither the doctors nor the patients know who gets which treatment until after the study.See study design
What are the potential side effects?
Sugammadex may cause side effects like allergic reactions or changes in heart rate. The usual combination of glycopyrrolate/neostigmine can also have side effects including dry mouth, blurred vision, and difficulty urinating.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman having a hysterectomy for prolapse or abnormal bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 hours postop
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 hours postop
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Void Test (Fail)
Void Test (Pass)
Trial Design
2Treatment groups
Active Control
Group I: SugammadexActive Control1 Intervention
Sugammadex dose=4 mg x kg
Group II: Standard of CareActive Control1 Intervention
Standard of care= glycopyrrolate and neostigmine (0.01 mg/kg - 50mg/kg)
Find a Location
Who is running the clinical trial?
West Virginia UniversityLead Sponsor
176 Previous Clinical Trials
60,134 Total Patients Enrolled
Omar Duenas Garcia, MDPrincipal InvestigatorWVU
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on dialysis or have severe kidney problems.I am allergic or might be allergic to the study drug, painkillers, muscle relaxants, or anesthesia medications.I do not have any health conditions that would prevent me from taking the study medication.I cannot have certain muscle relaxant reversal drugs after surgery due to my condition or past surgery.I will take toremifene around the same time as the study medication.I do not wish to participate in the study.I cannot take certain drugs used in this study due to allergies or side effects.I or someone in my family has had malignant hyperthermia.I am having a sling procedure along with my vaginal hysterectomy.You are allergic to sugammadex, neostigmine, or glycopyrrolate.I am a male.I am a woman having a hysterectomy for prolapse or abnormal bleeding.I have a condition that affects my muscle function.My surgery will be done using a laparoscopic or robotic method.You already have trouble with urination.
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.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Sugammadex
- Group 2: Standard of Care
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for eligible individuals in this clinical research?
"Clinicaltrials.gov denotes that this investigation is not presently seeking volunteers; the study went online on January 1st 2023 and was modified most recently in December 2022. Thankfully, 33 additional clinical trials are actively recruiting patients at present."
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