Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Feasibility of Neostigmine as a Reversal Agent of Neuromuscular Blockade for Intraoperative Neuromonitoring During Thyroid Surgery: a Prospective Randomized Controlled Study

Conditions
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Thyroid Diseases, Surgical Injury, Nerve Monitoring

Intervention / Treatment
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* Drug: Neostigmine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: open thyroid surgery with intraoperative neuromonitoring Exclusion Criteria: refusal to participate in the study rocuronium should not be used (e.g. renal dysfunction patient)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neostigmine<br>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. | Drug: Neostigmine<br>* 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.<br>* Other names: N group;|
| Placebo Comparator: Normal saline<br>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. | Drug: Normal saline<br>* 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.<br>* Other names: NS group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery of cricothyroid muscle twitching | Time from the rocuronium administration to recovery of cricothyroid muscle twitching | perioperative | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid surgery, recurrent laryngeal nerve, neostigmine, intraoperative neuromonitoring