Thyroid Surgery Clinical Trial
Official title:
Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery
The purpose of this study will explore the advantages of electrodes used for monitoring of the recurrent laryngeal nerve (RLN) in thyroid surgery
OBJECTIVES/HYPOTHESIS:
The purpose of this study will explore the advantages and applications of electrodes used
for monitoring of the recurrent laryngeal nerve (RLN) in thyroid surgery. We want to know
that if the monitoring system will decrease the rate of recurrent laryngeal nerve palsy.
STUDY DESIGN:
One hundred patients who undergoing thyroid surgery will be collected in this study.
Patients will be intubated for general anesthesia with a Medtronic Xomed Nerve Integrity
Monitor (NIM) EMG endotracheal tube (Jacksonville, Fla) that had 2 electrodes imbedded in
the wall of the endotracheal tube. These wires were placed up against each vocal cord. Two
grounding wires(needle No. 26) were placed up in the subcutaneous tissues of both shoulders.
The electrode wires, grounding wires, and nerve stimulator were connected to a monitoring
device (Medtronic NIM-Response) that recoded a visual evoked potential and audible beep to
each muscle contraction of a vocal cord. A Medtronic Xomed Prass monopolar nerve stimulator
wand was used to test the RLN intraoperatively and was set at 0.5mA. Direct physical
touching of the RLN with nerve stimulator using pulsed current would produce an audible
"beep-beep-beep".
CONCLUSION:
This study will be conducted in cooperation with Department of anesthesiology. The following
subjects will be collected and elucidated:
1. If the muscle relaxant used during surgery will affect the operation of RLN monitoring
system.
2. Can RLN monitoring system accurately identify the RLN
3. Can RLN monitoring system accurately predict the function of RLN
4. Can RLN monitoring system decrease the RLN palsy rate after thyroidectomy
5. Application of RLN monitoring to determine the safety and the benefit of vagal
stimulation at the beginning and the end of thyroid operation
6. Application of RLN monitoring to determine whether extensive dissection of RLN
increases the risk of nerve injury.
At least four papers will be written after this study with the topics as followings:
1. Influence of muscle relaxation on neuromonitoring of the recurrent laryngeal nerve
during thyroid surgery
2. Intraoperative neuromonitoring of the recurrent laryngeal nerve during thyroid surgery:
Plaudits and pitfalls 3. Vagal stimulation during intraoperative neuromonitoring of the
recurrent laryngeal nerve in thyroid operation.
4. Does extensive dissection of recurrent laryngeal nerve during thyroid operation increase
the risk of nerve injury? Our experience with the application of intraoperative
neuromonitoring
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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