Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05794503

Collaborator

(none)

230

Enrollment

Arms

21.1

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention Postoperative Laparoscopic Cholecystectomy Neuromuscular Blockade Sugammadex Neostigmine Neuromuscular Blocking Agents Physiological Effects of Drugs	Drug: Neostigmine Drug: Sugammadex	Early Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single site, randomized, controlledSingle site, randomized, controlled

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Blinded

Primary Purpose:

Treatment

Official Title:

Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Neostigmine	Drug: Neostigmine Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.
Active Comparator: Sugammadex	Drug: Sugammadex Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex

Arm

Intervention/Treatment

Active Comparator: Neostigmine

Drug: Neostigmine

Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.

Active Comparator: Sugammadex

Drug: Sugammadex

Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex

Outcome Measures

Primary Outcome Measures

Incidence rates of postoperative urinary retention (POUR) of sugammadex and neostigmine groups. [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tiffany B Moon, Associate Professor, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT05794503

Other Study ID Numbers:

STU-2022-1201

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

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

Neostigmine

Study Results

No Results Posted as of Apr 3, 2023