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

Postoperative Urinary Retention Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664633
• Other study ID #: 2107367192
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: West Virginia University
• Contact: Omar Duenas Garcia, MD
• Phone: 855-WVU-CARE
• Email: omar.duenasgarcia[@]hsc.wvu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Postoperative Urinary Retention
• Urinary Retention

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	West Virginia University Hospitals	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 4 hours postop
Primary	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	Up to 4 hours post-op