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

Sponsor

West Virginia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05664633

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Urinary Retention	Drug: Sugammadex	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sugammadex Sugammadex dose=4 mg x kg	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.
No Intervention: Standard of Care Standard of care= glycopyrrolate and neostigmine (0.01 mg/kg - 50mg/kg)

Arm

Intervention/Treatment

Active Comparator: Sugammadex

Sugammadex dose=4 mg x kg

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.

No Intervention: Standard of Care

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

Outcome Measures

Primary Outcome Measures

Void Test (Pass) [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) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Virginia University Hospitals	Morgantown	West Virginia	United States	26505

Sponsors and Collaborators

West Virginia University

Investigators

Principal Investigator: Omar Duenas Garcia, MD, WVU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Omar Duenas Garcia, Associate Professor, West Virginia University

ClinicalTrials.gov Identifier:

NCT05664633

Other Study ID Numbers:

2107367192

First Posted:

Dec 27, 2022

Last Update Posted:

Dec 27, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Urinary Retention

Study Results

No Results Posted as of Dec 27, 2022