Thyroid DiseasesNCT04873531
Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery
A study testing Neostigmine and Normal saline in people with Thyroid Diseases and Surgical Injury, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
For successful intraoperative neuromonitoring (IONM), adequate reversal of neuromuscular blocking agent is a prerequisite in thyroid surgery with . The aim of this study is to investigate the feasibility of neostigmine just after tracheal intubation on the IONM in thyroid surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thyroid Diseases, Surgical Injury, Nerve Monitoring
- What is being tested?
- Neostigmine and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2021to 31 Aug 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- open thyroid surgery with intraoperative neuromonitoring
Who cannot join
- refusal to participate in the study
- rocuronium should not be used (e.g. renal dysfunction patient)
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: Feasibility of Neostigmine as a Reversal Agent of Neuromuscular Blockade for Intraoperative Neuromonitoring During Thyroid Surgery: a Prospective Randomized Controlled Study
For successful intraoperative neuromonitoring (IONM), adequate reversal of neuromuscular blocking agent is a prerequisite in thyroid surgery with .
The aim of this study is to investigate the feasibility of neostigmine just after tracheal intubation on the IONM in thyroid surgery.
Read the detailed description
For successful intraoperative neuromonitoring (IONM), adequate reversal of neuromuscular blocking agent is a prerequisite in thyroid surgery with .
The aim of this study is to investigate the feasibility of neostigmine just after tracheal intubation on the IONM in thyroid surgery.
This study will be performed as a randomized controlled trial with two groups (N group: neostigmine group and NS group: normal saline group).
For the N group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation.
For the NS group, normal saline with a same volume of the N group will be administered just after tracheal intubation.
For all patients of two groups, investigators evaluate the quality of signal of IONM during the surgery.
- Conditions
- Thyroid Diseases, Surgical Injury, Nerve Monitoring
- Being tested
- Neostigmine, Normal saline
- Keywords
- thyroid surgery, recurrent laryngeal nerve, neostigmine, intraoperative neuromonitoring
- Medical subject headings
- Thyroid Diseases, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeostigmineDrug
Also called N group
For the N group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation.
Investigators evaluate the quality of signal of IONM during the surgery.
Normal salineDrug
Also called NS group
For the NS group, neostigmine normal saline (0.09 cc/kg; the same volume of the group N) will be administered just after tracheal intubation.
Investigators evaluate the quality of signal of IONM during the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Neostigmine | Experimental | For the Neostigmine (N) group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation.
Investigators evaluate the quality of signal of IONM during the surgery. Receives: Drug: Neostigmine |
| Normal saline | Placebo comparator | For the Normal saline (NS) group, normal saline with a same volume of the N group will be administered just after tracheal intubation.
Investigators evaluate the quality of signal of IONM during the surgery. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery of cricothyroid muscle twitching
Time from the rocuronium administration to recovery of cricothyroid muscle twitching
Measured: perioperative
Secondary outcomes (5)
amplitude of EMG for V1
micro-volts (uV), Electromyography amplitude of the vagus nerve before tumor manipulation
Measured: During surgery
amplitude of EMG for R1
micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve before tumor manipulation
Measured: During surgery
amplitude of EMG for R2
micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve after tumor removal
Measured: During surgery
amplitude of EMG for V2
micro-volts (uV), Electromyography amplitude of the vagus nerve after tumor removal
Measured: During surgery
number of patients with involuntary movements disrupting surgery
number, number of patients who move involuntarily during surgery, which disrupt and pause the surgery to prevent harmful events, such as tracheal injuries by a sharp surgical devices during the surgery
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start10 May 2021
- Primary completion23 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies 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
- Model description
- a randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 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, MD.PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873531
- Sponsor's protocol ID
- 10-2021-12
- Status last verified
- Mar 2022
- First submitted
- 26 Apr 2021
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: possible, If there would be reasonable explanation for sharing
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Neostigmine as a Reversal Agent of Neuromuscular Blockade for Intraoperative Neuromonitoring During Thyroid Surgery: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04873531
- Acronym / sponsor ID
- 10-2021-12
- Conditions
- Thyroid Diseases, Surgical Injury, Nerve Monitoring
- Keywords
- thyroid surgery, recurrent laryngeal nerve, neostigmine, intraoperative neuromonitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 10 May 2021 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 5 May 2021 (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.
For successful intraoperative neuromonitoring (IONM), adequate reversal of neuromuscular blocking agent is a prerequisite in thyroid surgery with .
The aim of this study is to investigate the feasibility of neostigmine just after tracheal intubation on the IONM in thyroid surgery.
Detailed description
For successful intraoperative neuromonitoring (IONM), adequate reversal of neuromuscular blocking agent is a prerequisite in thyroid surgery with .
The aim of this study is to investigate the feasibility of neostigmine just after tracheal intubation on the IONM in thyroid surgery.
This study will be performed as a randomized controlled trial with two groups (N group: neostigmine group and NS group: normal saline group).
For the N group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation.
For the NS group, normal saline with a same volume of the N group will be administered just after tracheal intubation.
For all patients of two groups, investigators evaluate the quality of signal of IONM during the surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- a randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Neostigmine | Experimental | Drug: NeostigmineFor the Neostigmine (N) group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation. Investigators evaluate the quality of signal of IONM during the surgery. |
| Normal saline | Placebo comparator | Drug: Normal salineFor the Normal saline (NS) group, normal saline with a same volume of the N group will be administered just after tracheal intubation. Investigators evaluate the quality of signal of IONM during the surgery. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- open thyroid surgery with intraoperative neuromonitoring
Key exclusion criteria (2 listed)
- refusal to participate in the study
- rocuronium should not be used (e.g. renal dysfunction patient)
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 |
|---|---|---|
| NeostigmineAlso: N groupFor the N group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation. Investigators evaluate the quality of signal of IONM during the surgery. | Drug | Neostigmine |
| Normal salineAlso: NS groupFor the NS group, neostigmine normal saline (0.09 cc/kg; the same volume of the group N) will be administered just after tracheal intubation. Investigators evaluate the quality of signal of IONM during the surgery. | Drug | Normal saline |
Primary outcome
Time to recovery of cricothyroid muscle twitching
Time frame: perioperative
Time from the rocuronium administration to recovery of cricothyroid muscle twitching
5 secondary outcomes
amplitude of EMG for V1
Time frame: During surgery
amplitude of EMG for R1
Time frame: During surgery
amplitude of EMG for R2
Time frame: During surgery
amplitude of EMG for V2
Time frame: During surgery
number of patients with involuntary movements disrupting surgery
Time frame: During surgery
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 2022.
- Individual participant dataSharing planned: No. possible, If there would be reasonable explanation for sharing
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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, MD.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 Neostigmine and Normal saline in people with Thyroid Diseases and Surgical Injury, 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 4 Mar 2022. 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. Some participants in this study may receive a placebo. 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?
Time to recovery of cricothyroid muscle twitching (time frame: perioperative). 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 4 Mar 2022.