Thyroid Intra-Operative InjuryNCT03911232
The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve
A study testing sugammadex in people with Thyroid Intra-Operative Injury, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Objectives: The use of neuromuscular blocking agent may interfere with the function of intraoperative neuromonitoring (IONM) in thyroid surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Thyroid Intra-Operative Injury
- What is being tested?
- sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2015to Mar 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy
Who cannot join
- Patients with a history of significant cardiac, pulmonary, hepatic, or renal disease, body mass index <18.5 or >35, chronic drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve During Thyroid Surgery
Objectives: The use of neuromuscular blocking agent may interfere with the function of intraoperative neuromonitoring (IONM) in thyroid surgery.
Read the detailed description
An enhanced neuromuscular-blockade (NMB) recovery protocol was investigated in a clinically applied during thyroid neural monitoring surgery. In as subsequent clinical application study, 60 patients who underwent thyroidectomy with IONM followed an enhanced NMB recovery protocol- rocuronium 0.6 mg/kg at anesthesia induction and sugammadex 2 mg/kg at operation start. Train-of-four (TOF) ratio was used for continuous quantitative monitoring of neuromuscular transmission.
- Conditions
- Thyroid Intra-Operative Injury
- Being tested
- sugammadex
- Keywords
- intraoperative neural monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugammadexDrug
Also called Bridion
standard general anesthesia protocol with sugammadex
| Study group | Role | What they receive |
|---|---|---|
| Enhanced recovery | Experimental | rocuronium 2 effective dose at anesthesia induction sugammadex after skin incision and before extubation (total 2 mg/kg iv) Receives: Drug: sugammadex |
| Conventional anesthesia | No intervention | standard general anesthesia protocol (1 effective dose of rocuronium at anesthesia induction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
sugammadex 2 mg/kg allows effective and rapid restoration of neuromuscular function suppressed by rocuronium
Electromyography signal to assess the quality of neuromonitoring
Measured: 1 month each case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Intra-Operative InjuryStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I-Cheng Lu, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911232
- Sponsor's protocol ID
- KMUH-IRB-E-20150023
- Status last verified
- Jun 2021
- First submitted
- 5 Dec 2016
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve During Thyroid Surgery
- ClinicalTrials.gov ID
- NCT03911232
- Acronym / sponsor ID
- KMUH-IRB-E-20150023
- Conditions
- Thyroid Intra-Operative Injury
- Keywords
- intraoperative neural monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Apr 2019 (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.
Objectives: The use of neuromuscular blocking agent may interfere with the function of intraoperative neuromonitoring (IONM) in thyroid surgery.
Detailed description
An enhanced neuromuscular-blockade (NMB) recovery protocol was investigated in a clinically applied during thyroid neural monitoring surgery. In as subsequent clinical application study, 60 patients who underwent thyroidectomy with IONM followed an enhanced NMB recovery protocol- rocuronium 0.6 mg/kg at anesthesia induction and sugammadex 2 mg/kg at operation start. Train-of-four (TOF) ratio was used for continuous quantitative monitoring of neuromuscular transmission.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced recovery | Experimental | Drug: sugammadexrocuronium 2 effective dose at anesthesia induction sugammadex after skin incision and before extubation (total 2 mg/kg iv) |
| Conventional anesthesia | No intervention | –standard general anesthesia protocol (1 effective dose of rocuronium at anesthesia induction) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy
Key exclusion criteria (1 listed)
- Patients with a history of significant cardiac, pulmonary, hepatic, or renal disease, body mass index <18.5 or >35, chronic drug or alcohol abuse
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 |
|---|---|---|
| sugammadexAlso: Bridionstandard general anesthesia protocol with sugammadex | Drug | Enhanced recovery |
Primary outcome
sugammadex 2 mg/kg allows effective and rapid restoration of neuromuscular function suppressed by rocuronium
Time frame: 1 month each case
Electromyography signal to assess the quality of neuromonitoring
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 30 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Thyroid Intra-Operative Injury
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
Recruiting
Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve in Thyroid Surgery
Laryngeal Nerve Injuries, Thyroidectomy
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 in people with Thyroid Intra-Operative Injury, run by Kaohsiung Medical University Chung-Ho Memorial 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 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 30 Jun 2021. 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?
sugammadex 2 mg/kg allows effective and rapid restoration of neuromuscular function suppressed by rocuronium (time frame: 1 month each case). 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 30 Jun 2021.