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

NCT ID: NCT05664633

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-06-30

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.

Conditions

Postoperative Urinary Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sugammadex

Sugammadex dose=4 mg x kg

Group Type: ACTIVE_COMPARATOR

Sugammadex

Intervention Type: DRUG

Sugammadex or G/N will be given at the end of the procedure once the surgeon communicates with the anesthesiologist. The surgeon will typically do this at the time of putting the closing sutures.

Standard of Care

Standard of care= glycopyrrolate and neostigmine (0.01 mg/kg - 50mg/kg)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sugammadex

Sugammadex or G/N will be given at the end of the procedure once the surgeon communicates with the anesthesiologist. The surgeon will typically do this at the time of putting the closing sutures.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Omar Duenas Garcia

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar Duenas Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

WVU

Other Identifiers

2107367192

Identifier Type: -

Identifier Source: org_study_id