General AnesthesiaNCT01980069
A Double-blind, Randomized, Parallel Design Study to Compare the Effectiveness of Sugammadex Versus Neostigmine in Improving Surgical Condition in Subjects Undergoing Laryngeal Microsurgery
A study testing Sugammadex and Neostigmine in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
Investigators hypothesized that the surgical condition will be improved with the use of sugammadex in patients undergoing laryngeal microsurgery. Investigators will compare the effect of sugammadex and neostigmine on the surgical condition during laryngeal microsurgery. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Sugammadex and Neostigmine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Oct 2014
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients of age over 20 years
- scheduled for laryngeal microsurgery under general anesthesia
Who cannot join
- anticipated difficult intubation, cervical spine disease, neuromuscular disease, acute or chronic renal failure, liver cirrhosis or liver failure
- history of allergy to nondepolarizing muscle relaxant
- history of malignant hyperthermia
- pregnant woman
- body mass index over 35 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Investigators hypothesized that the surgical condition will be improved with the use of sugammadex in patients undergoing laryngeal microsurgery. Investigators will compare the effect of sugammadex and neostigmine on the surgical condition during laryngeal microsurgery.
- Conditions
- General Anesthesia
- Being tested
- Sugammadex, Neostigmine
- Keywords
- Sugammadex, Neostigmine, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
In sugammadex group, sugammadex (Bridion, Merck Shart and Dohme (MSD), Oss, the Netherlands) will be administered intravenously in different doses according to the degree of muscle relaxation. Sugammadex 8 mg/kg will be administered if there is no response on post-tetanic count (PTC) stimulus. Sugammadex 4 mg/kg will be administered if PTC is more than 1 or 2. Sugammadex 2 mg/kg will be administered if T2 response appears on train-of-four (TOF) stimulus.
NeostigmineDrug
In neostigmine group, neostigmine 50 ㎍/kg will be administered intravenously with glycopyrrolate 10 ㎍/kg when the T2 response appears on TOF stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Neostigmine arm | Experimental | Neostigmine arm Receives: Drug: Neostigmine |
| Sugammadex arm | Active comparator | Sugammadex arm Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical condition
Primary outcome is the proportion of patients who have clinically acceptable surgical condition. The surgeon will evaluate the surgical condition as a surgical rating scale during surgery (extremely poor condition, poor condition, acceptable condition, good condition, optimal condition).
Measured: up to 1 hour after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980069
- Sponsor's protocol ID
- 4-2013-0451
- Status last verified
- Apr 2015
- First submitted
- 1 Nov 2013
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim HJ, Lee K, Park WK, Lee BR, Joo HM, Koh YW, Seo YW, Kim WS, Yoo YC. Deep neuromuscular block improves the surgical conditions for laryngeal microsurgery. Br J Anaesth. 2015 Dec;115(6):867-72. doi: 10.1093/bja/aev368.
PubMed 26582847
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Parallel Design Study to Compare the Effectiveness of Sugammadex Versus Neostigmine in Improving Surgical Condition in Subjects Undergoing Laryngeal Microsurgery
- ClinicalTrials.gov ID
- NCT01980069
- Acronym / sponsor ID
- 4-2013-0451
- Conditions
- General Anesthesia
- Keywords
- Sugammadex, Neostigmine, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Nov 2013 (estimated)
- 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.
Investigators hypothesized that the surgical condition will be improved with the use of sugammadex in patients undergoing laryngeal microsurgery. Investigators will compare the effect of sugammadex and neostigmine on the surgical condition during laryngeal microsurgery.
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 arm | Experimental | Drug: NeostigmineNeostigmine arm |
| Sugammadex arm | Active comparator | Drug: SugammadexSugammadex arm |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients of age over 20 years
- scheduled for laryngeal microsurgery under general anesthesia
Key exclusion criteria (5 listed)
- anticipated difficult intubation, cervical spine disease, neuromuscular disease, acute or chronic renal failure, liver cirrhosis or liver failure
- history of allergy to nondepolarizing muscle relaxant
- history of malignant hyperthermia
- pregnant woman
- body mass index over 35 kg/m2
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 |
|---|---|---|
| SugammadexIn sugammadex group, sugammadex (Bridion, Merck Shart and Dohme (MSD), Oss, the Netherlands) will be administered intravenously in different doses according to the degree of muscle relaxation. Sugammadex 8 mg/kg will be administered if there is no response on post-tetanic count (PTC) stimulus. Sugammadex 4 mg/kg will be administered if PTC is more than 1 or 2. Sugammadex 2 mg/kg will be administered if T2 response appears on train-of-four (TOF) stimulus. | Drug | Sugammadex arm |
| NeostigmineIn neostigmine group, neostigmine 50 ㎍/kg will be administered intravenously with glycopyrrolate 10 ㎍/kg when the T2 response appears on TOF stimuli. | Drug | Neostigmine arm |
Primary outcome
surgical condition
Time frame: up to 1 hour after the end of surgery
Primary outcome is the proportion of patients who have clinically acceptable surgical condition. The surgeon will evaluate the surgical condition as a surgical rating scale during surgery (extremely poor condition, poor condition, acceptable condition, good condition, optimal condition).
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 23 Apr 2015.
- Derived from this study: PubMed 26582847Kim HJ, Lee K, Park WK, Lee BR, Joo HM, Koh YW, Seo YW, Kim WS, Yoo YC. Deep neuromuscular block improves the surgical conditions for laryngeal microsurgery. Br J Anaesth. 2015 Dec;115(6):867-72. doi: 10.1093/bja/aev368.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex and Neostigmine in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 5 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 23 Apr 2015. 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 South Korea. 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?
surgical condition (time frame: up to 1 hour after the end of surgery). 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 NCT01980069, 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 23 Apr 2015; AzTrials last refreshed its copy on 27 Oct 2026.