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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-11

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single site, randomized, controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Blinded

Study Groups

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Neostigmine

One type of Neuromuscular Blockade Reversal Drug

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

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

Sugammadex

One type of Neuromuscular Blockade Reversal Drug

Group Type ACTIVE_COMPARATOR

Sugammadex

Intervention Type DRUG

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

Interventions

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Neostigmine

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

Intervention Type DRUG

Sugammadex

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes