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| Name | Class |
|---|---|
| SMG-SNU Boramae Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neostigmine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recovery of cricothyroid muscle twitching | Time from the rocuronium administration to recovery of cricothyroid muscle twitching | perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| amplitude of EMG for V1 | micro-volts (uV), Electromyography amplitude of the vagus nerve before tumor manipulation | During surgery |
| amplitude of EMG for R1 | micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve before tumor manipulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung-Man Lee, MD.PhD | SMG-SNU Boramae Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul | 07061 | South Korea |
possible, If there would be reasonable explanation for sharing
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D007431 | Intraoperative Complications |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009388 | Neostigmine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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a randomized controlled trial
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For participant, they will be blind to the group which they will be assigned. The surgeon, who will evaluate the quality of the signal, will be blinded to patient's group.
|
| Normal saline | Drug | 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. |
|
|
| During surgery |
| amplitude of EMG for R2 | micro-volts (uV), Electromyography amplitude of the recurrent laryngeal nerve after tumor removal | During surgery |
| amplitude of EMG for V2 | micro-volts (uV), Electromyography amplitude of the vagus nerve after tumor removal | 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 | During surgery |
| D009861 |
| Onium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |