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

West Virginia University

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Postoperative Urinary Retention

Treatments

Drug: Sugammadex

Study type

Interventional

Funder types

Other

Identifiers

NCT05664633

2107367192

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)