RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2023-08

Study Completion:2024-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05664633

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)

Inclusion Criteria

Exclusion 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)

Contacts and Locations

Study Contact

Omar Duenas Garcia, MD

CONTACT

855-WVU-CARE

omar.duenasgarcia@hsc.wvu.edu

Principal Investigator

Omar Duenas Garcia, MD

PRINCIPAL_INVESTIGATOR

WVU

Study Locations (Sites)

West Virginia University Hospitals

Morgantown, West Virginia, 26505

United States

Collaborators and Investigators

Sponsor: West Virginia University

Omar Duenas Garcia, MD, PRINCIPAL_INVESTIGATOR, WVU

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08

Study Completion Date2024-06

Study Record Updates

Study Start Date2023-08

Study Completion Date2024-06

Terms related to this study

Additional Relevant MeSH Terms

Postoperative Urinary Retention