NCT05276804

Brief Summary

The primary aim of this study will be to compare the rate of postoperative urinary retention between patients receiving Sugammadex and those receiving traditional reversal agents

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 13, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

July 9, 2025

Completed
Last Updated

July 9, 2025

Status Verified

February 1, 2024

Enrollment Period

2.4 years

First QC Date

March 1, 2022

Results QC Date

May 14, 2025

Last Update Submit

June 18, 2025

Conditions

Postoperative Urinary Retention

Keywords

Sugammadex

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Urinary Retention

    Urinary retention is defined as the inability to void at six hours postoperatively, which will be recorded in the postoperative recovery area and the same definition for urinary retention will be applied to the comparative retrospective cohort

    6 hours postop

Secondary Outcomes (2)

  • Length of Stay (Days)

    From post op to discharge (up to 365 days)

  • Hospital Cost

    At discharge (up to 365 days)

Other Outcomes (4)

  • Quality of Life Survey

    Week 2

  • Operation Time

    Day 1

  • Morphine Milligram Equivalents

    Day 1

  • +1 more other outcomes

Study Arms (2)

Sugammadex

EXPERIMENTAL

Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. Sugammadex will be used for reversal of their neuromuscular blockade. The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.

Drug: Sugammadex

Retrospective cohort

NO INTERVENTION

Retrospective cohort of patients who did not receive Sugammadex

Interventions

SugammadexDRUG

The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.

Sugammadex

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over the age of 18
  • Undergoing laparoscopic inguinal hernia repair at Carolinas Medical Center by attending surgeons within the Division of Gastrointestinal and Minimally Invasive Surgery
  • Unilateral or bilateral inguinal hernia repair; may have concurrent umbilical hernia repair performed
  • Agreeable to participation in the study

You may not qualify if:

  • Patients who are having concurrent ventral or flank hernias repaired at time of operation or are having an inguinal hernia repair along with another operation (e.g.
  • laparoscopic cholecystectomy)
  • End-stage renal disease (Creatinine clearance less than 30)
  • Neuromuscular disease
  • Prior adverse reactions to Sugammadex
  • Patients who do not provide consent for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Gregory T. Scarola
Organization
Atrium Health
gregory.scarola@advocatehealth.org
704 355-5379

Study Officials

  • Brant T Heniford, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2022

First Posted

March 11, 2022

Study Start

April 13, 2022

Primary Completion

September 3, 2024

Study Completion

September 3, 2024

Last Updated

July 9, 2025

Results First Posted

July 9, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)