Sugammadex for Postoperative Urinary Retention

Recruiting in Palo Alto (17 mi)

Overseen by Omar Duenas Garcia, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: West Virginia University

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial compares two methods for reversing muscle relaxation during surgery. One method acts like a magnet to remove muscle relaxants, while the other helps the body naturally counteract muscle relaxation. The study focuses on patients having a total vaginal hysterectomy with or without additional pelvic procedures.

Eligibility Criteria

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.

Inclusion Criteria

I am a woman having a hysterectomy for prolapse or abnormal bleeding.

Exclusion 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.

Participant Groups

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.

Group I: Standard of Care Active Control 1 Intervention

Standard of care= glycopyrrolate and neostigmine (0.01 mg/kg - 50mg/kg)

Group II: Sugammadex Active Control 1 Intervention

Sugammadex dose=4 mg x kg

Sugammadex is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Bridion for:

• Reversal of Neuromuscular Blockade induced by rocuronium bromide and vecuronium bromide

🇪🇺 Approved in European Union as Bridion for:

• Reversal of Neuromuscular Blockade induced by rocuronium bromide and vecuronium bromide

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

West Virginia University Hospitals Morgantown, WV

Who Is Running the Clinical Trial?

West Virginia University Lead Sponsor

References