The Role of Sugammadex in Posotoperative Urinary Retention in Patients Undergoing Pelvic Floor Reconstructive Procedures
Postoperative Urinary Retention
About this trial
This is an interventional treatment trial for Postoperative Urinary Retention
Eligibility Criteria
Inclusion Criteria: female patients undergoing a vaginal hysterectomy with the indications of pelvic organ prolapse or abnormal uterine bleeding Exclusion Criteria: Patients who are already known to have voiding dysfunction Patients who have a contraindication or intolerance to any of the drugs used in the study Has a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery. Has a neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments. Is dialysis-dependent or has severe renal insufficiency, defined as estimated creatinine clearance of <30 mL/min. Has or is suspected of having a personal history or family history (parents, grandparents, or siblings) of malignant hyperthermia. Has or is suspected of having an allergy (e.g., hypersensitivity and/or anaphylactic reaction) to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia. Has received or is planned to receive toremifene within 24 hours before or within 24 hours after study medication administration. Has any condition that would contraindicate the administration of study medication. Is pregnant, is attempting to become pregnant, or is lactating. Is currently participating in or has participated in an interventional clinical trial (including any other current or ongoing trial with a sugammadex treatment arm) with an investigational compound or device within 30 days of signing the informed consent form of this current trial. Male patients Patients undergoing a conventional laparoscopic or robotic approach Patients having a midurethral sling in addition to the vaginal hysterectomy Patients declining to participate in the study Patients allergic to any of the drugs used in the study (sugammadex, neostigmine and/or glycopyrrolate)
Sites / Locations
- West Virginia University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Sugammadex
Standard of Care
Sugammadex dose=4 mg x kg
Standard of care= glycopyrrolate and neostigmine (0.01 mg/kg - 50mg/kg)