Urinary Retention PostoperativePhase 4NCT05794503
Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex
A Phase 4 study testing Neostigmine and Sugammadex in people with Urinary Retention Postoperative and Laparoscopic Cholecystectomy, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention Postoperative, Laparoscopic Cholecystectomy, Neuromuscular Blockade
- What is being tested?
- Neostigmine and Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center
Dallas, Texas, 75390-9068
About this study
Official title: Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Urinary Retention Postoperative, Laparoscopic Cholecystectomy, Neuromuscular Blockade, Sugammadex, Neostigmine, Neuromuscular Blocking Agents
- Being tested
- Neostigmine, Sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeostigmineDrug
Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.
SugammadexDrug
Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex
| Study group | Role | What they receive |
|---|---|---|
| Neostigmine | Active comparator | One type of Neuromuscular Blockade Reversal Drug Receives: Drug: Neostigmine |
| Sugammadex | Active comparator | One type of Neuromuscular Blockade Reversal Drug Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Inability to spontaneously urinate and a bladder volume ≥ 300 mL
- Postvoid residual > 150 mL
- Need for insertion of Foley catheter or straight catheter
Measured: In the post-operative anesthesia care unit, bladder volumes and time to void were measured, assessed up to 24 hours or patient discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start11 Sep 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Retention PostoperativeStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single site, randomized, controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiffany B Moon, University of Texas Southwestern Medical Center
- Investigators
- Tiffany Moon, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794503
- Sponsor's protocol ID
- STU-2022-1201
- Status last verified
- Sep 2024
- First submitted
- 20 Mar 2023
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41789933
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05794503
- Acronym / sponsor ID
- STU-2022-1201
- Conditions
- Urinary Retention Postoperative, Laparoscopic Cholecystectomy, Neuromuscular Blockade, Sugammadex, Neostigmine, Neuromuscular Blocking Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single site, randomized, controlled
| Arm | Type | Receives |
|---|---|---|
| Neostigmine | Active comparator | Drug: NeostigmineOne type of Neuromuscular Blockade Reversal Drug |
| Sugammadex | Active comparator | Drug: SugammadexOne type of Neuromuscular Blockade Reversal Drug |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeostigmineMaintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine. | Drug | Neostigmine |
| SugammadexMaintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex | Drug | Sugammadex |
Primary outcome
Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups
Time frame: In the post-operative anesthesia care unit, bladder volumes and time to void were measured, assessed up to 24 hours or patient discharge.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41789933Diesch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Moon, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neostigmine and Sugammadex in people with Urinary Retention Postoperative and Laparoscopic Cholecystectomy, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups (time frame: In the post-operative anesthesia care unit, bladder volumes and time to void were measured, assessed up to 24 hours or patient discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05794503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.