The Role of Sugammadex in Posotoperative Urinary Retention in Patients Undergoing Pelvic Floor Reconstructive Procedures

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The Investigator will perform a single-institution randomized double-blinded controlled trial comparing intraoperative Sugammadex vs. standard dose of glycopyrrolate/neostigmine combination for participants undergoing a total vaginal hysterectomy with or without pelvic organ prolapse procedures under general endotracheal anesthesia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West Virginia University

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)