The POUR (Postoperative Urinary Retention) Study
NCT05276804 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171
Last updated 2025-07-09
Summary
The primary aim of this study will be to compare the rate of postoperative urinary retention between patients receiving Sugammadex and those receiving traditional reversal agents
Conditions
- Postoperative Urinary Retention
Interventions
- DRUG
-
Sugammadex
The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
Brant T Heniford, MD · Wake Forest University Health Sciences
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-13
- Primary Completion
- 2024-09-03
- Completion
- 2024-09-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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