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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05276804
Other study ID # IRB00083113
Secondary ID 01-22-45E
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 13, 2022
Est. completion date June 2025

Study information

Verified date February 2024
Source Wake Forest University Health Sciences
Contact Brant T Heniford, MD
Phone 704-355-3168
Email Todd.Heniford@AtriumHealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Postoperative urinary retention following laparoscopic inguinal hernia repair occurs in approximately one out of ten patients. The more rapid reversal of neuromuscular blockade with Sugammadex has empirically been associated with low rates of postoperative urinary retention. In this study, patients will receive Sugammadex following laparoscopic inguinal hernia repair and then be retrospectively matched against a group of patients who did not receive Sugammadex. 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 (e.g. neostigmine which has a retention rate of 5-11%). We will also examine difference in cost and quality of life between the two groups. Our hypothesis is that the use of Sugammadex will decrease rate of postoperative urinary retention, decrease associated cost, such as need for admission, and not negatively impact quality of life.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date June 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sugammadex
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.

Locations

Country Name City State
United States Carolinas Medical Center Charlotte North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Length of stay (Days) Patients will be followed from post surgery until discharge to determine the interim time From post up to discharge (up to 365 days)
Secondary Hospital Cost Patient costs associated with procedure and hospital stay At discharge (up to 365 days)
Secondary Quality of life - Carolinas Comfort Scale Score range 0-115 . Lower scores indicate more favorable health Postop clinic visit (typically 1-2 weeks post surgery)
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