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

Primary Purpose

Postoperative Urinary Retention

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sugammadex
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Urinary Retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • West Virginia University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Sugammadex

Standard of Care

Arm Description

Sugammadex dose=4 mg x kg

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

Outcomes

Primary Outcome Measures

Void Test (Pass)
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)
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

Secondary Outcome Measures

Full Information

First Posted
December 15, 2022
Last Updated
July 22, 2023
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT05664633
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Urinary Retention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sugammadex
Arm Type
Active Comparator
Arm Description
Sugammadex dose=4 mg x kg
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of care= glycopyrrolate and neostigmine (0.01 mg/kg - 50mg/kg)
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Void Test (Pass)
Description
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.
Time Frame
Up to 4 hours postop
Title
Void Test (Fail)
Description
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
Time Frame
Up to 4 hours post-op

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Duenas Garcia, MD
Phone
855-WVU-CARE
Email
omar.duenasgarcia@hsc.wvu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Duenas Garcia, MD
Organizational Affiliation
WVU
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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