THYROIDECTOMYIONMNCT02377882
The Optimal Dosage of Rocuronium for Intraoperative Neuromonitoring During Thyroid Surgery
An observational study of THYROIDECTOMY, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators tried to explore an alternative non-depolarizing muscle relaxant (rocuronium) and its optimal dosage to replace succinylcholine for IONM during thyroid surgery.Time frame of outcome measure was during 30 to 70min after rocuronium injection. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- THYROIDECTOMY
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Feb 2010
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were planned to receive thyroidectomy
Who may be able to join
- Clinical diagnosis of thyroid tumor
Who cannot join
- neuromuscular disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Hospital
Kaohsiung City, 807
About this study
Official title: The Optimal Dosage of Neuromuscular Blocking Agent for Intraoperative Neuromonitoring During Thyroid Surgery
The investigators tried to explore an alternative non-depolarizing muscle relaxant (rocuronium) and its optimal dosage to replace succinylcholine for IONM during thyroid surgery.Time frame of outcome measure was during 30 to 70min after rocuronium injection. Specific time points at which the will be assessed and for EMG signals will be presented.
Read the detailed description
Recurrent laryngeal nerve (RLN) palsy is the most common and serious complication after thyroid surgery, and ranks among the leading reasons for medicolegal litigation of surgeons. Intraoperative neuromonitoring (IONM) are being applied to prevent RLN injury during thyroid surgery. IONM has been used as a means not only to localize and identify the RLN, but also to predict cord function and elucidate the surgical pitfalls during preparation of RLN.
Muscle relaxant is necessary for general anesthesia; it can facilitate tracheal intubation and stable conditions for surgery. However, the use of muscle relaxant might diminish the EMG response during IONM and interfere with the interpretation of IONM results. Eighty patients were randomized to receive one (group 1, n=40) or two (group 2, n=40) effective dose (ED95) of rocuronium to facilitate EMG endotracheal tube insertion. Evoked potentials were obtained per 5 minutes by stimulating vagus nerve from the time point of 30 to 70 minutes after administration of rocuronium. The magnitude of evoked potential at each time point and tracheal intubating condition were compared between groups. Accelerometry [twitch (% TW)] was used to monitor the quantitative degree of neuromuscular transmission. The aim of this study was to explore an alternative non-depolarizing muscle relaxant (Rocuronium) and its optimal dosage to replace succinylcholine for IONM. The ED95 of rocuronium is 0.3mg/kg and 2×ED95 is generally recommended as a standard intubation dosage.
- Conditions
- THYROIDECTOMY
- Keywords
- Intra-operative neuromonitoring, Neuromuscular blocking agent, Rocuronium, Thyroid surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to detect V1 and V2 signals
V1 signal means an EMG signals obtained from the vagus nerve before identification of RLN.
V2 signal-The final testing of the vagus nerve EMG signals was performed after complete hemostasis of the operative field.
The amplitude (μV) of V1 and V2 signals and the correlated degree of neuromuscular transmission (% TW) were recorded and analyzed.
Measured: WITHIN 2 DAYS, follow up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for THYROIDECTOMYStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koung-Shin Chu, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- I-Chen Lu, M.D., Study chair, Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377882
- Sponsor's protocol ID
- KMUH-IRB-980170
- Acronym
- IONM
- Status last verified
- Feb 2015
- First submitted
- 8 Jul 2010
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dralle H, Sekulla C, Lorenz K, Brauckhoff M, Machens A; German IONM Study Group. Intraoperative monitoring of the recurrent laryngeal nerve in thyroid surgery. World J Surg. 2008 Jul;32(7):1358-66. doi: 10.1007/s00268-008-9483-2.
PubMed 18305996Chan WF, Lo CY. Pitfalls of intraoperative neuromonitoring for predicting postoperative recurrent laryngeal nerve function during thyroidectomy. World J Surg. 2006 May;30(5):806-12. doi: 10.1007/s00268-005-0355-8.
PubMed 16680596Chan WF, Lang BH, Lo CY. The role of intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy: a comparative study on 1000 nerves at risk. Surgery. 2006 Dec;140(6):866-72; discussion 872-3. doi: 10.1016/j.surg.2006.07.017. Epub 2006 Sep 18.
PubMed 17188132
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Dosage of Neuromuscular Blocking Agent for Intraoperative Neuromonitoring During Thyroid Surgery
- ClinicalTrials.gov ID
- NCT02377882
- Acronym / sponsor ID
- IONM / KMUH-IRB-980170
- Conditions
- THYROIDECTOMY
- Keywords
- Intra-operative neuromonitoring, Neuromuscular blocking agent, Rocuronium, Thyroid surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 4 Mar 2015 (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.
The investigators tried to explore an alternative non-depolarizing muscle relaxant (rocuronium) and its optimal dosage to replace succinylcholine for IONM during thyroid surgery.Time frame of outcome measure was during 30 to 70min after rocuronium injection. Specific time points at which the will be assessed and for EMG signals will be presented.
Detailed description
Recurrent laryngeal nerve (RLN) palsy is the most common and serious complication after thyroid surgery, and ranks among the leading reasons for medicolegal litigation of surgeons. Intraoperative neuromonitoring (IONM) are being applied to prevent RLN injury during thyroid surgery. IONM has been used as a means not only to localize and identify the RLN, but also to predict cord function and elucidate the surgical pitfalls during preparation of RLN.
Muscle relaxant is necessary for general anesthesia; it can facilitate tracheal intubation and stable conditions for surgery. However, the use of muscle relaxant might diminish the EMG response during IONM and interfere with the interpretation of IONM results. Eighty patients were randomized to receive one (group 1, n=40) or two (group 2, n=40) effective dose (ED95) of rocuronium to facilitate EMG endotracheal tube insertion. Evoked potentials were obtained per 5 minutes by stimulating vagus nerve from the time point of 30 to 70 minutes after administration of rocuronium. The magnitude of evoked potential at each time point and tracheal intubating condition were compared between groups. Accelerometry [twitch (% TW)] was used to monitor the quantitative degree of neuromuscular transmission. The aim of this study was to explore an alternative non-depolarizing muscle relaxant (Rocuronium) and its optimal dosage to replace succinylcholine for IONM. The ED95 of rocuronium is 0.3mg/kg and 2×ED95 is generally recommended as a standard intubation dosage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were planned to receive thyroidectomy
Key inclusion criteria (1 listed)
- Clinical diagnosis of thyroid tumor
Key exclusion criteria (1 listed)
- neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The time to detect V1 and V2 signals
Time frame: WITHIN 2 DAYS, follow up to 6 months
V1 signal means an EMG signals obtained from the vagus nerve before identification of RLN. V2 signal-The final testing of the vagus nerve EMG signals was performed after complete hemostasis of the operative field. The amplitude (μV) of V1 and V2 signals and the correlated degree of neuromuscular transmission (% TW) were recorded and analyzed.
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 4 Mar 2015.
- Background: PubMed 18305996Dralle H, Sekulla C, Lorenz K, Brauckhoff M, Machens A; German IONM Study Group. Intraoperative monitoring of the recurrent laryngeal nerve in thyroid surgery. World J Surg. 2008 Jul;32(7):1358-66. doi: 10.1007/s00268-008-9483-2.
- Background: PubMed 16680596Chan WF, Lo CY. Pitfalls of intraoperative neuromonitoring for predicting postoperative recurrent laryngeal nerve function during thyroidectomy. World J Surg. 2006 May;30(5):806-12. doi: 10.1007/s00268-005-0355-8.
- Background: PubMed 17188132Chan WF, Lang BH, Lo CY. The role of intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy: a comparative study on 1000 nerves at risk. Surgery. 2006 Dec;140(6):866-72; discussion 872-3. doi: 10.1016/j.surg.2006.07.017. Epub 2006 Sep 18.
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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.
I-Chen Lu, M.D. study chair
Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of THYROIDECTOMY, 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 4 Mar 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 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?
The time to detect V1 and V2 signals (time frame: WITHIN 2 DAYS, follow up to 6 months). 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 NCT02377882, which also lists 3 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 4 Mar 2015.