Clinical trial NCT05794503: Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex
Official title: Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Retention Postoperative
Laparoscopic Cholecystectomy
Neuromuscular Blockade
Sugammadex
Neostigmine
Neuromuscular Blocking Agents
Physiological Effects of Drugs
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single site, randomized, controlled
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups
timeFrame: In the post-operative anesthesia care unit, bladder volumes and time to void were measured, assessed up to 24 hours or patient discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Tiffany Moon, MD
role: PRINCIPAL_INVESTIGATOR
References: