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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neostigmine | Active Comparator | One type of Neuromuscular Blockade Reversal Drug |
|
| Sugammadex | Active Comparator | One type of Neuromuscular Blockade Reversal Drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neostigmine | Drug | Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine. |
|
| 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:
| In the post-operative anesthesia care unit, bladder volumes and time to void were measured, assessed up to 24 hours or patient discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany Moon, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390-9068 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41789933 | Derived | Diesch CE, Vo MX, Salinas K, Grant KN, Flindt GH, Mohapatra SG, Berry A, Oh MW, Chen JL, Gasanova I, Moon T. Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine versus Sugammadex in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial. Anesth Analg. 2026 Mar 6. doi: 10.1213/ANE.0000000000008000. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neostigmine | One type of Neuromuscular Blockade Reversal Drug Neostigmine: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine. |
| FG001 | Sugammadex |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2023 |
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Single site, randomized, controlled
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Blinded
| Sugammadex | Drug | Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex |
|
One type of Neuromuscular Blockade Reversal Drug
Sugammadex: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neostigmine | One type of Neuromuscular Blockade Reversal Drug Neostigmine: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine. |
| BG001 | Sugammadex | One type of Neuromuscular Blockade Reversal Drug Sugammadex: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Posted | Count of Participants | Participants | In the post-operative anesthesia care unit, bladder volumes and time to void were measured, assessed up to 24 hours or patient discharge. |
|
|
|
Up to post operative day 30
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neostigmine | One type of Neuromuscular Blockade Reversal Drug Neostigmine: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine. | 0 | 112 | 0 | 112 | 0 | 112 |
| EG001 | Sugammadex | One type of Neuromuscular Blockade Reversal Drug Sugammadex: Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex | 0 | 118 | 0 | 118 | 0 | 118 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Moon, MD | UT Southwestern Medical Center | (214) 648-6400 | tiffany.moon@utsouthwestern.edu |
| Sep 30, 2024 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009388 | Neostigmine |
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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