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

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05794503
• Other study ID #: STU-2022-1201
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 11, 2023
• Est. completion date: September 2027

Study information

• Verified date: November 2023
• Source: University of Texas Southwestern Medical Center
• Contact: Tiffany Moon, MD
• Phone: (469) 419-5790
• Email: tiffany.moon[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Neostigmine
Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.
• Sugammadex
Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rates of postoperative urinary retention (POUR) of sugammadex and neostigmine groups.		18 months