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

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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy; Neuromuscular Blockade; Physiological Effects of Drugs; Urinary Retention Postoperative; Sugammadex; Neostigmine; Neuromuscular Blocking Agents
• Intervention / Treatment: Drug: Neostigmine; Drug: Sugammadex

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 Type: Interventional
• Enrollment (Actual): 235
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-9068
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neostigmine; One type of Neuromuscular Blockade Reversal Drug	Drug: Neostigmine; Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.
Active Comparator: Sugammadex; One type of Neuromuscular Blockade Reversal Drug	Drug: Sugammadex; Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups	Measure pre- and post-void bladder volumes, void volume, and the time to void after operation. The count of participants with Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups is being reported. POUR will be defined as: Inability to spontaneously urinate and a bladder volume ≥ 300 mL; Postvoid residual > 150 mL; Need for insertion of Foley catheter or straight catheter	In the post-operative anesthesia care unit, bladder volumes and time to void were measured, assessed up to 24 hours or patient discharge.

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Tiffany Moon, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Retention; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: STU-2022-1201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes