Neuromuscular BlockadeNCT02330172
Sugammadex Provide Better Surgical Condition Compared With Neostigmine in Laryngeal Microsurgery.
A study testing Injection of neostigmine or sugammadex in people with Neuromuscular Blockade, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to make a comparison of surgical condition and recovery time between rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Injection of neostigmine or sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Aug 2015
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist Physical status classification 1 or 2 elective laryngeal microsurgery under general anesthesia
Who cannot join
- BMI >25 or < 20 kg/m2 Patients taking intercurrent medication Glutamic Oxalacetate Transaminase or Glutamic Pyruvate Transaminase > 40 IU/L, Cr > 1.4 mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Sugammadex With Neostigmine in Laryngeal Microsurgery.
This study aims to make a comparison of surgical condition and recovery time between rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group.
Read the detailed description
This study aims to make a comparison of surgical condition and recovery time between moderate neuromuscular bloackade with reversal using neostigmine group and deep neuromuscular bloackade with reversal using sugammadex group.
- Conditions
- Neuromuscular Blockade
- Being tested
- Injection of neostigmine or sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of neostigmine or sugammadexOther
Also called neostigmin or sugammadex
At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.
| Study group | Role | What they receive |
|---|---|---|
| rocuronium 0.45 - neostigmine | Active comparator | when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.
When the end of operation, a injection of neostigmine or sugammadex will be administered. Receives: Other: Injection of neostigmine or sugammadex |
| rocuronium 0.9 - sugammadex | Active comparator | When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.
When the end of operation,, a injection of neostigmine or sugammadex be administered. Receives: Other: Injection of neostigmine or sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laryngoscopic Score
Definitions for evaluation of Laryngoscopycondition.
: Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy.
Variables Excellent Good Poor
Measured: At the beginning of surgery, the surgeon rated the laryngoscopy condition
Secondary outcomes (1)
Recovery Time From Neuromuscular Blockade
We measured recovery time ffrom the injection of neostigmine or sugammadex to TOF ratio 0.9
Measured: from the injection of neostigmine or sugammadex up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startMay 2014
- Primary completionAug 2015
- Study completionAug 2015
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 Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ah Young Oh, Principal investigator, Bungdang Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330172
- Sponsor's protocol ID
- B1312230009
- Status last verified
- Jul 2015
- First submitted
- 9 Dec 2014
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Choi ES, Oh AY, Koo BW, Hwang JW, Han JW, Seo KS, Ahn SH, Jeong WJ. Comparison of reversal with neostigmine of low-dose rocuronium vs. reversal with sugammadex of high-dose rocuronium for a short procedure. Anaesthesia. 2017 Oct;72(10):1185-1190. doi: 10.1111/anae.13894. Epub 2017 May 11.
PubMed 28493510
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Sugammadex With Neostigmine in Laryngeal Microsurgery.
- ClinicalTrials.gov ID
- NCT02330172
- Acronym / sponsor ID
- B1312230009
- Conditions
- Neuromuscular Blockade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Posted 17 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to make a comparison of surgical condition and recovery time between rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group.
Detailed description
This study aims to make a comparison of surgical condition and recovery time between moderate neuromuscular bloackade with reversal using neostigmine group and deep neuromuscular bloackade with reversal using sugammadex group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rocuronium 0.45 - neostigmine | Active comparator | Other: Injection of neostigmine or sugammadexwhen anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation. When the end of operation, a injection of neostigmine or sugammadex will be administered. |
| rocuronium 0.9 - sugammadex | Active comparator | Other: Injection of neostigmine or sugammadexWhen anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation. When the end of operation,, a injection of neostigmine or sugammadex be administered. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist Physical status classification 1 or 2 elective laryngeal microsurgery under general anesthesia
Key exclusion criteria (1 listed)
- BMI >25 or < 20 kg/m2 Patients taking intercurrent medication Glutamic Oxalacetate Transaminase or Glutamic Pyruvate Transaminase > 40 IU/L, Cr > 1.4 mg/dl
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 |
|---|---|---|
| Injection of neostigmine or sugammadexAlso: neostigmin or sugammadexAt anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation. During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected. | Other | rocuronium 0.45 - neostigmine, rocuronium 0.9 - sugammadex |
Primary outcome
Laryngoscopic Score
Time frame: At the beginning of surgery, the surgeon rated the laryngoscopy condition
Definitions for evaluation of Laryngoscopycondition. : Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy. Variables Excellent Good Poor
1 secondary outcome
Recovery Time From Neuromuscular Blockade
Time frame: from the injection of neostigmine or sugammadex up to 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28493510Choi ES, Oh AY, Koo BW, Hwang JW, Han JW, Seo KS, Ahn SH, Jeong WJ. Comparison of reversal with neostigmine of low-dose rocuronium vs. reversal with sugammadex of high-dose rocuronium for a short procedure. Anaesthesia. 2017 Oct;72(10):1185-1190. doi: 10.1111/anae.13894. Epub 2017 May 11.
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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.
Ah Young Oh principal investigator
Bungdang Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of neostigmine or sugammadex in people with Neuromuscular Blockade, run by Seoul National University Hospital 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 1 inclusion and 1 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 17 Apr 2017. 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?
Yes. Results are posted in the registry (first posted 17 Apr 2017). 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?
Laryngoscopic Score (time frame: At the beginning of surgery, the surgeon rated the laryngoscopy condition). 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 NCT02330172, 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 17 Apr 2017.