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

NCT05794503 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: STU-2022-1201
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention Postoperative; Laparoscopic Cholecystectomy; Neuromuscular Blockade; Sugammadex; Neostigmine; Neuromuscular Blocking Agents; Physiological Effects of Drugs

Outcome Measures

Primary Outcomes (1)

• 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: 1. Inability to spontaneously urinate and a bladder volume ≥ 300 mL 2. Postvoid residual \> 150 mL 3. 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.

Study Arms (2)

Neostigmine

ACTIVE COMPARATOR

One type of Neuromuscular Blockade Reversal Drug

Drug: Neostigmine

Sugammadex

ACTIVE COMPARATOR

One type of Neuromuscular Blockade Reversal Drug

Drug: Sugammadex

Interventions

Neostigmine DRUG

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

Neostigmine

Sugammadex DRUG

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

Sugammadex

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390-9068, United States

Location

MeSH Terms

Interventions

Neostigmine; Sugammadex

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Tiffany Moon, MD
• Organization: UT Southwestern Medical Center

tiffany.moon@utsouthwestern.edu

(214) 648-6400

Study Officials

• Tiffany Moon, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single site, randomized, controlled

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: September 11, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)