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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05794503
Other study ID # STU-2022-1201
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date September 11, 2023
Est. completion date September 2027

Study information

Verified date November 2023
Source University of Texas Southwestern Medical Center
Contact Tiffany Moon, MD
Phone (469) 419-5790
Email tiffany.moon@utsouthwestern.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is intended to be a single-site, prospective, randomized, controlled study that intends to enroll a total of 230 patients undergoing laparoscopic cholecystectomy at Parkland Hospital. Patients will be randomized to receive either neostigmine or sugammadex for reversal of rocuronium-induced neuromuscular blockade. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. To account for protocol deviations and patient dropout, up to 250 randomization envelopes will be made and enrollment will continue until there are 230 completed enrollments.


Description:

Objective: To determine the incidence of postoperative urinary retention after reversal of rocuronium-induced neuromuscular blockade by neostigmine versus sugammadex in patients undergoing laparoscopic cholecystectomy. Hypothesis: Subjects who are reversed with sugammadex will have less postoperative urinary retention compared to subjects who are reversed with neostigmine.


Recruitment information / eligibility

Status Recruiting
Enrollment 230
Est. completion date September 2027
Est. primary completion date September 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 18-80 years old - Undergoing laparoscopic cholecystectomy - Anticipated surgical duration <2 hours - ASA physical status classification 1-3 - Willing and able to consent in English or Spanish - No personal history of neuromuscular disease Exclusion Criteria: - Preoperative urinary catheter - History of problems with urination - Current use of anticholinergic medications (e.g., antihistamines, phenothiazines, antidepressants, antipsychotics) - Current UTI or urogenital problem (incontinence, known bladder retention, prostate hypertrophy) - Planned intraoperative insertion of a urinary catheter - ESRD (GRF <30 mL/min) - ESLD (AST or ALT > 3x reference range) - Planned postoperative intubation/ventilation or admission to ICU - Allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium - Pregnant or nursing women - "Stat" (emergent) cases - Known or suspected neurological condition (e.g., Alzheimer's, h/o of stroke, multiple sclerosis, Parkinson's) - Patients on toremifene (a selective estrogen receptor modulator) - Women on oral contraceptives who do not wish to use a non-hormonal method of contraception for 7 days following surgery

Study Design


Intervention

Drug:
Neostigmine
Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.
Sugammadex
Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex

Locations

Country Name City State
United States UT Southwestern Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence rates of postoperative urinary retention (POUR) of sugammadex and neostigmine groups. 18 months
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