Clinical trial NCT05664633: The Role of Sugammadex in Posotoperative Urinary Retention in Patients Undergoing Pelvic Floor Reconstructive Procedures
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Postoperative Urinary Retention
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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)

Primary outcomes:
measure: Void Test (Pass)
timeFrame: Up to 4 hours postop
measure: Void Test (Fail)
timeFrame: Up to 4 hours post-op
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: WVU
name: Omar Duenas Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References: