Head and Neck SurgeryNCT06398899
Sugammadex v.s. Neostigmine/Glycopyrrolate
A study testing Group S: sugammadex injection and Group N: neostigmine/glycopyrrolate in people with Head and Neck Surgery and Chronic Sinusitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The aim of study is to clarify the role of sugammadex in ENT surgery patients with a prior history of postoperative urinary retention, benign prostatic hypertrophy, or a history of prostate cancer, to prevent postoperative urinary retention. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Head and Neck Surgery, Chronic Sinusitis, Chronic Otitis Media
- What is being tested?
- Group S: sugammadex injection and Group N: neostigmine/glycopyrrolate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2024to 12 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ENT surgery patients whose surgery is expected to take less than three hours and no planned Foley catheter
- high risk of postoperative urinary retention, including
- prior history of postoperative urinary retention
- benign prostatic hypertrophy
- history of prostate cancer
Who cannot join
- refusal or inability to provide informed consent
- age younger than 18 years
- American Society of Anesthesiologists class more than III
- pregnancy
- impaired renal function (creatinine clearance < 30 mL/min)
- allergy to a study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sugammadex Compared With Neostigmine/Glycopyrrolate in Impact of Postoperative Urinary Retention for ENT Surgery Patients With High-risk of Dysuria
The aim of study is to clarify the role of sugammadex in ENT surgery patients with a prior history of postoperative urinary retention, benign prostatic hypertrophy, or a history of prostate cancer, to prevent postoperative urinary retention. The main question it aims to answer are:
- Anticholinergic agent interferes the postoperative urination
- Sugammadex does not interfere postoperative urination Sugammadex can be recommended for these patients with high risk in postoperative urinary retention in the future.
Read the detailed description
Investigators will evaluate the benefit of sugammadex in reducing postoperative urinary retention for these head and neck surgery patients with high-risk for dysuria. The definition of high-risk of dysuria is patient with a prior history of urinary retention, benign prostatic hypertrophy, or a history of prostate cancer.
Patients scheduled to undergo ENT surgery within Three hours of expected surgical time are enrolled. These patients are associated with high-risk of postoperative urinary retention, including prior history of postoperative urinary retention, benign prostatic hypertrophy, or a history of prostate cancer. They are randomly divided these patients into sugammadex group (Group S) and neostigmine/glycopyrrolate group (Group N), sugammadex or neostigmine/glycopyrrolate are used during recovery period of anesthesia, to compare the incidences of postoperative urinary retention, nausea/vomiting, bradycardia, hypotension, and dry mouth in these patients after ENT surgery. Sugammadex can be recommended for these high-risk patients in the future.
- Being tested
- Group S: sugammadex injection, Group N: neostigmine/glycopyrrolate
- Keywords
- Sugammadex, anticholinergic drug, postoperative urinary retention, ENT surgery, neostigmine
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group S: sugammadex injectionDrug
Also called Bridion
Reversal agent: sugammadex
Group N: neostigmine/glycopyrrolateDrug
Also called vagostin injection/glycopyrodyn
Reversal agent: glycopyrrolate and neostigmine
| Study group | Role | What they receive |
|---|---|---|
| Group S | Experimental | Sugammadex as reversal agent Receives: Drug: Group S: sugammadex injection |
| Group N | Active comparator | neostigmine and glycopyrrolate as reversal agent Receives: Drug: Group N: neostigmine/glycopyrrolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative urinary retention
Postoperative urinary retention is defined as patient discomfort or a palpable bladder, with a bladder volume of ≥400 mL confirmed by bladder scan or catheterization, requiring intervention.
Measured: up to 48 hours
Secondary outcomes (4)
postoperative nausea and vomiting
postoperative nausea and vomiting
Measured: 48 hours
bradycardia
Bradycardia was defined as a heart rate of less than 50 beats per minute.
Measured: 24 hours
thirsty intensity
thirsty intensity during postanesthesia care unit
Measured: 24 hour
length of hospital stay
length of hospital stay
Measured: during admission (assessed up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 May 2024
- Primary completion12 Jun 2025
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck SurgeryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sugammadex or Neostigmine/Glycopyrrolate
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PEILIN LN, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398899
- Sponsor's protocol ID
- 202307081MINA
- Status last verified
- Aug 2025
- First submitted
- 5 Mar 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugammadex Compared With Neostigmine/Glycopyrrolate in Impact of Postoperative Urinary Retention for ENT Surgery Patients With High-risk of Dysuria
- ClinicalTrials.gov ID
- NCT06398899
- Acronym / sponsor ID
- 202307081MINA
- Keywords
- Sugammadex, anticholinergic drug, postoperative urinary retention, ENT surgery, neostigmine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of study is to clarify the role of sugammadex in ENT surgery patients with a prior history of postoperative urinary retention, benign prostatic hypertrophy, or a history of prostate cancer, to prevent postoperative urinary retention. The main question it aims to answer are:
- Anticholinergic agent interferes the postoperative urination
- Sugammadex does not interfere postoperative urination Sugammadex can be recommended for these patients with high risk in postoperative urinary retention in the future.
Detailed description
Investigators will evaluate the benefit of sugammadex in reducing postoperative urinary retention for these head and neck surgery patients with high-risk for dysuria. The definition of high-risk of dysuria is patient with a prior history of urinary retention, benign prostatic hypertrophy, or a history of prostate cancer.
Patients scheduled to undergo ENT surgery within Three hours of expected surgical time are enrolled. These patients are associated with high-risk of postoperative urinary retention, including prior history of postoperative urinary retention, benign prostatic hypertrophy, or a history of prostate cancer. They are randomly divided these patients into sugammadex group (Group S) and neostigmine/glycopyrrolate group (Group N), sugammadex or neostigmine/glycopyrrolate are used during recovery period of anesthesia, to compare the incidences of postoperative urinary retention, nausea/vomiting, bradycardia, hypotension, and dry mouth in these patients after ENT surgery. Sugammadex can be recommended for these high-risk patients in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sugammadex or Neostigmine/Glycopyrrolate
| Arm | Type | Receives |
|---|---|---|
| Group S | Experimental | Drug: Group S: sugammadex injectionSugammadex as reversal agent |
| Group N | Active comparator | Drug: Group N: neostigmine/glycopyrrolateneostigmine and glycopyrrolate as reversal agent |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ENT surgery patients whose surgery is expected to take less than three hours and no planned Foley catheter
- high risk of postoperative urinary retention, including
Key exclusion criteria (6 listed)
- refusal or inability to provide informed consent
- age younger than 18 years
- American Society of Anesthesiologists class more than III
- pregnancy
- impaired renal function (creatinine clearance < 30 mL/min)
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 |
|---|---|---|
| Group S: sugammadex injectionAlso: BridionReversal agent: sugammadex | Drug | Group S |
| Group N: neostigmine/glycopyrrolateAlso: vagostin injection/glycopyrodynReversal agent: glycopyrrolate and neostigmine | Drug | Group N |
Primary outcome
postoperative urinary retention
Time frame: up to 48 hours
Postoperative urinary retention is defined as patient discomfort or a palpable bladder, with a bladder volume of ≥400 mL confirmed by bladder scan or catheterization, requiring intervention.
4 secondary outcomes
postoperative nausea and vomiting
Time frame: 48 hours
bradycardia
Time frame: 24 hours
thirsty intensity
Time frame: 24 hour
length of hospital stay
Time frame: during admission (assessed up to 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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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.
PEILIN LN principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group S: sugammadex injection and Group N: neostigmine/glycopyrrolate in people with Head and Neck Surgery and Chronic Sinusitis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 6 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 12 Sep 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 Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative urinary retention (time frame: up to 48 hours). 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 12 Sep 2025.