Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex

The University of Texas System (UT)

Status and phase

Completed

Phase 4

Conditions

Urinary Retention Postoperative

Sugammadex

Neuromuscular Blocking Agents

Physiological Effects of Drugs

Laparoscopic Cholecystectomy

Neostigmine

Neuromuscular Blockade

Treatments

Drug: Sugammadex

Drug: Neostigmine

Study type

Interventional

Funder types

Other

Identifiers

NCT05794503

STU-2022-1201

Details and patient eligibility

About

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.

Full 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.

Enrollment

235 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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