Neostigmine vs Sugammadex for Postoperative Urinary Retention

Recruiting in Palo Alto (17 mi)

Overseen by Tiffany Moon, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is intended to be a single-site, prospective, randomized, controlled study that intends to enroll a total of 230 patients undergoing laparoscopic cholecystectomy at Parkland Hospital. Patients will be randomized to receive either neostigmine or sugammadex for reversal of rocuronium-induced neuromuscular blockade. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. To account for protocol deviations and patient dropout, up to 250 randomization envelopes will be made and enrollment will continue until there are 230 completed enrollments.

Eligibility Criteria

This trial is for adults aged 18-80 undergoing laparoscopic cholecystectomy with an expected surgery time under 2 hours. They should be in relatively good health (ASA status 1-3) and not have neuromuscular diseases. Excluded are those needing post-op ICU, with neurological conditions, pregnant/nursing women not using non-hormonal contraception, UTI or urogenital issues, severe kidney/liver disease, allergies to study drugs, on anticholinergics or toremifene.

Inclusion Criteria

I am scheduled for a laparoscopic surgery to remove my gallbladder.

I am in good to moderate health with some medical problems.

I can give my consent in English or Spanish.

Exclusion Criteria

I am currently taking medication that affects my nervous system.

You are allergic to sugammadex, neostigmine, glycopyrrolate, or rocuronium.

I am scheduled to have a urinary catheter placed during surgery.

Treatment Details

Interventions

• Neostigmine (Cholinesterase Inhibitor)
• Sugammadex (Selective Relaxant Binding Agent)

Trial Overview The study compares two drugs used after surgery to reverse muscle relaxation caused by rocuronium: Neostigmine and Sugammadex. It's a controlled trial where patients are randomly chosen to receive one of the two drugs following standard anesthesia protocol during their gallbladder removal surgery.

Participant Groups

Group I: Neostigmine Active Control 1 Intervention

One type of Neuromuscular Blockade Reversal Drug

Group II: Sugammadex Active Control 1 Intervention

One type of Neuromuscular Blockade Reversal Drug

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

🇺🇸 Approved in United States as Prostigmin for:

• Myasthenia Gravis
• Reversal of Neuromuscular Blockade
• Urinary Retention

🇪🇺 Approved in European Union as Neostigmine for:

• Myasthenia Gravis
• Reversal of Nondepolarizing Muscle Relaxants

🇮🇳 Approved in India as Neostigmine for:

• Myasthenia Gravis
• Reversal of Neuromuscular Blockade

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UT Southwestern Medical Center Dallas, TX

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center Lead Sponsor

References