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

Primary Purpose

Urinary Retention Postoperative, Laparoscopic Cholecystectomy, Neuromuscular Blockade

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Neostigmine
Sugammadex
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • UT Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Neostigmine

Sugammadex

Arm Description

One type of Neuromuscular Blockade Reversal Drug

One type of Neuromuscular Blockade Reversal Drug

Outcomes

Primary Outcome Measures

Incidence rates of postoperative urinary retention (POUR) of sugammadex and neostigmine groups.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2023
Last Updated
September 5, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05794503
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention Postoperative, Laparoscopic Cholecystectomy, Neuromuscular Blockade, Sugammadex, Neostigmine, Neuromuscular Blocking Agents, Physiological Effects of Drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Single site, randomized, controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinded
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neostigmine
Arm Type
Active Comparator
Arm Description
One type of Neuromuscular Blockade Reversal Drug
Arm Title
Sugammadex
Arm Type
Active Comparator
Arm Description
One type of Neuromuscular Blockade Reversal Drug
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Intervention Description
Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex
Primary Outcome Measure Information:
Title
Incidence rates of postoperative urinary retention (POUR) of sugammadex and neostigmine groups.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Moon, MD
Phone
(469) 419-5790
Email
tiffany.moon@utsouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Moon, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9068
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Moon, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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