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
Overview
- Phase
- Phase 1
- Intervention
- Sugammadex
- Conditions
- Postoperative Urinary Retention
- Sponsor
- West Virginia University
- Enrollment
- 80
- Primary Endpoint
- Void Test (Pass)
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
Omar Duenas Garcia
Associate Professor
West Virginia University
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.
Arms & Interventions
Sugammadex
Sugammadex dose=4 mg x kg
Intervention: Sugammadex
Outcomes
Primary Outcomes
Void Test (Pass)
Time Frame: Up to 4 hours postop
Number of patients that Pass the Void Test. Once the patients are oriented and before leaving PACU, their bladder will be backfilled with 300 ccs of normal saline or at capacity. Then 30 minutes will be given to void. The voided volume will be measured using a toilet hat, and the post-void residual will then be measured using a bladder scanner.
Void Test (Fail)
Time Frame: Up to 4 hours post-op
Number of patients that Fail the Void Test. Once the patients are oriented and before leaving PACU, their bladder will be backfilled with 300 ccs of normal saline or at capacity. Then 30 minutes will be given to void. If the patients are unable to void or if the post-void residual is \> than 100 ml by bladder scanner, then it will be considered that those patients failed the voiding trial