Neuromuscular BlockadePhase 4NCT05545280
Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block
A Phase 4 study testing Neostigmine with glycopyrrolate and Sugammadex in people with Neuromuscular Blockade, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The investigators propose a randomized trial comparing sugammadex and neostigmine for the reversal of neuromuscular blocks induced by rocuronium or vecuronium in adults having general anesthesia with muscular block for noncardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Neostigmine with glycopyrrolate and Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 7 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature;
- Adults having noncardiac surgery with expected surgery duration ≥ 2 hours;
- General anesthesia requiring endotracheal intubation and neuromuscular block with rocuronium or vecuronium;
- Planned administration of sugammadex or neostigmine for reversal of the neuromuscular block at the end of surgery;
- American Society of Anesthesiologists (ASA) physical status 1-3;
- Age ≥ 65 years.
Who cannot join
- Contraindications to the class of drugs under study;
- Preoperative urinary catheter;
- Planned intraoperative insertion of a urinary catheter;
- Neurosurgery (except spine surgery), intraabdominal or retroperitoneal surgeries including but not limited to any kind of laparoscopies, or surgeries in kidneys, ureters or urine bladder.
- Planned postoperative admission to the ICU;
- Severe preoperative hepatic impairment (≥3 times increase in aspartate aminotransferase or alanine aminotransferase as per reference range) or renal impairment (estimated GFR < 30 ml/min or end-stage renal disease requiring scheduled dialysis.);
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- History of bladder cancer;
- Presence of a sacral nerve stimulator;
- Current use of anticholinergic medications such as antihistamines, phenothiazines, antidepressants or antipsychotics;
- Urinary tract infections or other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which promote urinary retention;
- Known or suspected neurological conditions such as Alzheimer's disease, stroke, poliomyelitis, cerebral palsy, multiple sclerosis, spinal lesions, or Parkinson's disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block by Neostigmine or Sugammadex: A Randomized Controlled Trial
The investigators propose a randomized trial comparing sugammadex and neostigmine for the reversal of neuromuscular blocks induced by rocuronium or vecuronium in adults having general anesthesia with muscular block for noncardiac surgery.
Read the detailed description
All patients will be asked to void before they are transferred to the operating room. Patients will be seen shortly before anesthetic induction (baseline, Visit 1). As this is a pragmatic trial, no restrictions to anesthetic management other than the random allocation to sugammadex or neostigmine are planned.
As part of local standards, it is recommended to maintain a moderate block of 1 to 2 twitch responses to train-of-four (TOF) stimulation throughout surgery.
Randomized treatments will be implemented by clinicians in collaboration with research personnel. Patients will be randomized shortly before the reversal of the neuromuscular block. At the time of randomization, the administration of either neostigmine or sugammadex need to be possible. If e.g. the neuromuscular block is too deep to be reversed with neostigmine, patients will not be randomized and excluded from the study.
The anesthesiologist in charge will be informed on the patient's allocation to either the sugammadex or neostigmine group by an unblinded investigator. Patients will be monitored for twitch responses towards the end of surgery to determine the timing and dose for the reversal agent. The twitch response will be measured using a quantitative, acceleromyographic monitoring device. For sugammadex, 4 mg/kg is recommended if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to (TOF) stimulation. Alternatively, 2 mg/kg is recommended if spontaneous recovery has reached the reappearance of the second twitch in response to TOF stimulation. In the neostigmine group, neostigmine 2.5 mg with glycopyrrolate 0.5 mg will be administered as an initial dose. Neostigmine and glycopyrrolate are to be administered in a fixed ratio, and only if the second twitch in response to TOF stimulation has appeared. The initial dose can be repeated up to a ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate. However, the final decision of the dose will be up to the attending anesthesiologist. The administered dose will be recorded. All patients are required to have a documented TOF ratio > 0.9 before extubation Visit 2 is one hour after surgery in the post anesthesia care unit (PACU). The third Visit is within 4 to 6 hours after surgery on the regular ward. Visit 4 and 5 will be in the morning and afternoon of the first day after surgery (postoperative day (POD) 1). Visit 5 on the afternoon of POD 1 will be the last follow-up and the end of a patient's participation in the study. Thereafter, data will be recorded from electronical medical records until POD 4 or discharge, whichever comes first.
- Conditions
- Neuromuscular Blockade
- Being tested
- Neostigmine with glycopyrrolate, Sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine with glycopyrrolateDrug
Administration by intravenous infusion
SugammadexDrug
Administration by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Neostigmine | Active comparator | Reversal of Neuromuscular Block by Neostigmine. Receives: Drug: Neostigmine with glycopyrrolate |
| Sugammadex | Active comparator | Reversal of Neuromuscular Block by Sugammadex. Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Residual in PACU
The primary outcome of urinary retention is assessed by post-void bladder volume.
Measured: 1 hour after surgery, which started from out of operation room
Secondary outcomes (1)
Number of Participants Who Needed a Urinary Catheter
participants who needed a urinary catheter within 24 hours after surgery
Measured: within 24 hours after out of operation room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Dec 2023
- Primary completion7 Aug 2024
- Study completion7 Aug 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.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kurt Ruetzler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545280
- Sponsor's protocol ID
- 22-745
- Status last verified
- Feb 2025
- First submitted
- 12 Sep 2022
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block by Neostigmine or Sugammadex: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05545280
- Acronym / sponsor ID
- 22-745
- Conditions
- Neuromuscular Blockade
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a randomized trial comparing sugammadex and neostigmine for the reversal of neuromuscular blocks induced by rocuronium or vecuronium in adults having general anesthesia with muscular block for noncardiac surgery.
Detailed description
All patients will be asked to void before they are transferred to the operating room. Patients will be seen shortly before anesthetic induction (baseline, Visit 1). As this is a pragmatic trial, no restrictions to anesthetic management other than the random allocation to sugammadex or neostigmine are planned.
As part of local standards, it is recommended to maintain a moderate block of 1 to 2 twitch responses to train-of-four (TOF) stimulation throughout surgery.
Randomized treatments will be implemented by clinicians in collaboration with research personnel. Patients will be randomized shortly before the reversal of the neuromuscular block. At the time of randomization, the administration of either neostigmine or sugammadex need to be possible. If e.g. the neuromuscular block is too deep to be reversed with neostigmine, patients will not be randomized and excluded from the study.
The anesthesiologist in charge will be informed on the patient's allocation to either the sugammadex or neostigmine group by an unblinded investigator. Patients will be monitored for twitch responses towards the end of surgery to determine the timing and dose for the reversal agent. The twitch response will be measured using a quantitative, acceleromyographic monitoring device. For sugammadex, 4 mg/kg is recommended if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to (TOF) stimulation. Alternatively, 2 mg/kg is recommended if spontaneous recovery has reached the reappearance of the second twitch in response to TOF stimulation. In the neostigmine group, neostigmine 2.5 mg with glycopyrrolate 0.5 mg will be administered as an initial dose. Neostigmine and glycopyrrolate are to be administered in a fixed ratio, and only if the second twitch in response to TOF stimulation has appeared. The initial dose can be repeated up to a ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate. However, the final decision of the dose will be up to the attending anesthesiologist. The administered dose will be recorded. All patients are required to have a documented TOF ratio > 0.9 before extubation Visit 2 is one hour after surgery in the post anesthesia care unit (PACU). The third Visit is within 4 to 6 hours after surgery on the regular ward. Visit 4 and 5 will be in the morning and afternoon of the first day after surgery (postoperative day (POD) 1). Visit 5 on the afternoon of POD 1 will be the last follow-up and the end of a patient's participation in the study. Thereafter, data will be recorded from electronical medical records until POD 4 or discharge, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neostigmine | Active comparator | Drug: Neostigmine with glycopyrrolateReversal of Neuromuscular Block by Neostigmine. |
| Sugammadex | Active comparator | Drug: SugammadexReversal of Neuromuscular Block by Sugammadex. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed Consent as documented by signature;
- Adults having noncardiac surgery with expected surgery duration ≥ 2 hours;
- General anesthesia requiring endotracheal intubation and neuromuscular block with rocuronium or vecuronium;
- Planned administration of sugammadex or neostigmine for reversal of the neuromuscular block at the end of surgery;
- American Society of Anesthesiologists (ASA) physical status 1-3;
Key exclusion criteria (11 listed)
- Contraindications to the class of drugs under study;
- Preoperative urinary catheter;
- Planned intraoperative insertion of a urinary catheter;
- Neurosurgery (except spine surgery), intraabdominal or retroperitoneal surgeries including but not limited to any kind of laparoscopies, or surgeries in kidneys, ureters or urine bladder.
- Planned postoperative admission to the ICU;
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 |
|---|---|---|
| Neostigmine with glycopyrrolateAdministration by intravenous infusion | Drug | Neostigmine |
| SugammadexAdministration by intravenous infusion | Drug | Sugammadex |
Primary outcome
Urine Residual in PACU
Time frame: 1 hour after surgery, which started from out of operation room
The primary outcome of urinary retention is assessed by post-void bladder volume.
1 secondary outcome
Number of Participants Who Needed a Urinary Catheter
Time frame: within 24 hours after out of operation room
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kurt Ruetzler, MD principal investigator
The Cleveland Clinic
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 with glycopyrrolate and Sugammadex in people with Neuromuscular Blockade, run by The Cleveland Clinic 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 11 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 10 Feb 2025. 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 10 Feb 2025). 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?
Urine Residual in PACU (time frame: 1 hour after surgery, which started from out of operation room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.