Thyroid SurgeryNCT03689413
Adequate Dosage of Sugammadex on Thyroid Surgery
A study testing Sugammadex 200 MG in 2 ML Injection in people with Thyroid Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study was designed to compare two dosage of sugammadex after tracheal intubation for optimal condition of continuous intraoperative neuromonitoring in thyroid surgery to protect recurrent laryngeal nerve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Surgery
- What is being tested?
- Sugammadex 200 MG in 2 ML Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2018to 28 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who need to open thyroid surgery
Who cannot join
- Who doesn't agree to enroll
- Who has to receive other drug rather than rocuronium for muscle relaxant
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061
About this study
Official title: Comparison of Sugammadex Dosages to Reverse the Effect of Rocuronium for Continuous Intraoperative Neuromonitoring in Thyroid Surgery
This study was designed to compare two dosage of sugammadex after tracheal intubation for optimal condition of continuous intraoperative neuromonitoring in thyroid surgery to protect recurrent laryngeal nerve.
Read the detailed description
Vocal cord paralysis is not a rare complication in thyroid surgery. Nerve monitoring technique has been developed, and many clinicians use the technique for saving the concerned nerves. Many studies showed that the effect of sugammadex on reverse of neuromuscular blocking after tracheal intubation. However, optimal dosage was not founded for sugammadex.
This randomized controlled trial is to compare 1 mg/kg and 2 mg/kg as dosage of sugammadex for optimal continuous intraoperative neuromonitoring in thyroid surgery to prevent vocal cord paralysis.
- Conditions
- Thyroid Surgery
- Being tested
- Sugammadex 200 MG in 2 ML Injection
- Keywords
- neuromonitoring, thyroid surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex 200 MG in 2 ML InjectionDrug
Also called Bridion
1 mg/kg or 2 mg/kg intravenous injection for each group (1 mg/kg group, 2 mg/kg group) after tracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| 1 mg/kg | Experimental | For '1 mg/kg' group, sugammadex of 1 mg/kg (ex. 60 mg for 60 kg patient) will be administered to the assigned patient for this group after tracheal intubation.
We will use Sugammadex 200 MG in 2 ML Injection for this. Receives: Drug: Sugammadex 200 MG in 2 ML Injection |
| 2 mg/kg | Active comparator | For '2 mg/kg' group, sugammadex of 2 mg/kg (ex. 120 mg for 60 kg patient) will be administered to the assigned patient for this group after tracheal intubation.
We will use Sugammadex 200 MG in 2 ML Injection for this. Receives: Drug: Sugammadex 200 MG in 2 ML Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of signal of neuromonitoring
During operation, surgeon evaluate the quality of signal of neuromonitoring on the basis of NIM III device.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Oct 2018
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thyroid SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jung-Man Lee, Seoul National University Hospital
- Investigators
- Jung-Man Lee, M.D.,PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689413
- Sponsor's protocol ID
- 30-2018-45
- Status last verified
- Jun 2020
- First submitted
- 27 Sep 2018
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21.
PubMed 19933538Empis de Vendin O, Schmartz D, Brunaud L, Fuchs-Buder T. Recurrent Laryngeal Nerve Monitoring and Rocuronium: A Selective Sugammadex Reversal Protocol. World J Surg. 2017 Sep;41(9):2298-2303. doi: 10.1007/s00268-017-4004-9.
PubMed 28349321Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8(8):CD012763. doi: 10.1002/14651858.CD012763.
PubMed 28806470Lu IC, Wu CW, Chang PY, Chen HY, Tseng KY, Randolph GW, Cheng KI, Chiang FY. Reversal of rocuronium-induced neuromuscular blockade by sugammadex allows for optimization of neural monitoring of the recurrent laryngeal nerve. Laryngoscope. 2016 Apr;126(4):1014-9. doi: 10.1002/lary.25577. Epub 2016 Jan 9.
PubMed 26748952
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sugammadex Dosages to Reverse the Effect of Rocuronium for Continuous Intraoperative Neuromonitoring in Thyroid Surgery
- ClinicalTrials.gov ID
- NCT03689413
- Acronym / sponsor ID
- 30-2018-45
- Conditions
- Thyroid Surgery
- Keywords
- neuromonitoring, thyroid surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 28 Sep 2018 (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.
This study was designed to compare two dosage of sugammadex after tracheal intubation for optimal condition of continuous intraoperative neuromonitoring in thyroid surgery to protect recurrent laryngeal nerve.
Detailed description
Vocal cord paralysis is not a rare complication in thyroid surgery. Nerve monitoring technique has been developed, and many clinicians use the technique for saving the concerned nerves. Many studies showed that the effect of sugammadex on reverse of neuromuscular blocking after tracheal intubation. However, optimal dosage was not founded for sugammadex.
This randomized controlled trial is to compare 1 mg/kg and 2 mg/kg as dosage of sugammadex for optimal continuous intraoperative neuromonitoring in thyroid surgery to prevent vocal cord paralysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 mg/kg | Experimental | Drug: Sugammadex 200 MG in 2 ML InjectionFor '1 mg/kg' group, sugammadex of 1 mg/kg (ex. 60 mg for 60 kg patient) will be administered to the assigned patient for this group after tracheal intubation. We will use Sugammadex 200 MG in 2 ML Injection for this. |
| 2 mg/kg | Active comparator | Drug: Sugammadex 200 MG in 2 ML InjectionFor '2 mg/kg' group, sugammadex of 2 mg/kg (ex. 120 mg for 60 kg patient) will be administered to the assigned patient for this group after tracheal intubation. We will use Sugammadex 200 MG in 2 ML Injection for this. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who need to open thyroid surgery
Key exclusion criteria (2 listed)
- Who doesn't agree to enroll
- Who has to receive other drug rather than rocuronium for muscle relaxant
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 |
|---|---|---|
| Sugammadex 200 MG in 2 ML InjectionAlso: Bridion1 mg/kg or 2 mg/kg intravenous injection for each group (1 mg/kg group, 2 mg/kg group) after tracheal intubation | Drug | 1 mg/kg, 2 mg/kg |
Primary outcome
Quality of signal of neuromonitoring
Time frame: intraoperative
During operation, surgeon evaluate the quality of signal of neuromonitoring on the basis of NIM III device.
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 11 Jun 2020.
- Background: PubMed 19933538Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21.
- Background: PubMed 28349321Empis de Vendin O, Schmartz D, Brunaud L, Fuchs-Buder T. Recurrent Laryngeal Nerve Monitoring and Rocuronium: A Selective Sugammadex Reversal Protocol. World J Surg. 2017 Sep;41(9):2298-2303. doi: 10.1007/s00268-017-4004-9.
- Background: PubMed 28806470Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8(8):CD012763. doi: 10.1002/14651858.CD012763.
- Background: PubMed 26748952Lu IC, Wu CW, Chang PY, Chen HY, Tseng KY, Randolph GW, Cheng KI, Chiang FY. Reversal of rocuronium-induced neuromuscular blockade by sugammadex allows for optimization of neural monitoring of the recurrent laryngeal nerve. Laryngoscope. 2016 Apr;126(4):1014-9. doi: 10.1002/lary.25577. Epub 2016 Jan 9.
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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.
Jung-Man Lee, M.D.,PhD principal investigator
SMG-SNU Boramae Medical Center
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 200 MG in 2 ML Injection in people with Thyroid Surgery, 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 2 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 11 Jun 2020. 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?
Quality of signal of neuromonitoring (time frame: intraoperative). 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 NCT03689413, which also lists 4 linked publications.
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 11 Jun 2020.