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

Description

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.

Conditions

Postoperative Urinary Retention

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Study Overview

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Study Details

Study overview

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.

A Randomized Clinical Trial to Determine the Effect of Transient Postoperative Urinary Retention Using Sugammadex (4 mg x kg) Versus Glycopyrrolate and Neostigmine (0.01 mg/kg - 50mg/kg) in Patients Undergoing Vaginal Hysterectomies With and Without Pelvic Organ Prolapse Procedures: A Pilot Study

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

Condition
Postoperative Urinary Retention
Intervention / Treatment

-

Contacts and Locations

Morgantown

West Virginia University Hospitals, Morgantown, West Virginia, United States, 26505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * female patients undergoing a vaginal hysterectomy with the indications of pelvic organ prolapse or abnormal uterine bleeding
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

West Virginia University,

Omar Duenas Garcia, MD, PRINCIPAL_INVESTIGATOR, WVU

Study Record Dates

2024-06