Clinical trial NCT00629746: Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery
Official title: Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Surgery
Recurrent Laryngeal Nerve
Electromyographic Monitoring
Keywords: Thyroid
RLN
EMG
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2008-03-06
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study will explore the advantages of electrodes used for monitoring of the recurrent laryngeal nerve (RLN) in thyroid surgery

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Thyroid disease for operation

Exclusion Criteria:

* N/A

Primary outcomes:
measure: If the muscle relaxant used during surgery will affect the operation of RLN monitoring system.
timeFrame: during operation
Secondary outcomes:
measure: Can RLN monitoring system accurately predict the function of RLN Can RLN monitoring system decrease the RLN palsy rate after thyroidectomy
timeFrame: early postoperation period
measure: Can standardization of IONM procedures further lower the RLN palsy rate
timeFrame: early postoperation period
measure: Dose IONM help to decrease the RLN palsy rate during difficult thyroid operations
timeFrame: early postoperation period
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Otolaryngology- Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan
state: Kaohsiung City
Study officials:
affiliation: Department of Otolaryngology- Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan
name: Feng-Yu Chiang, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Otolaryngology- Head and Neck Surgery,Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan
name: Che-Wei Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu CW, Dionigi G, Chen HC, Chen HY, Lee KW, Lu IC, Chang PY, Hsiao PJ, Ho KY, Chiang FY. Vagal nerve stimulation without dissecting the carotid sheath during intraoperative neuromonitoring of the recurrent laryngeal nerve in thyroid surgery. Head Neck. 2013 Oct;35(10):1443-7. doi: 10.1002/hed.23154. Epub 2012 Sep 18.
citation: Chiang FY, Lu IC, Tsai CJ, Hsiao PJ, Lee KW, Wu CW. Detecting and identifying nonrecurrent laryngeal nerve with the application of intraoperative neuromonitoring during thyroid and parathyroid operation. Am J Otolaryngol. 2012 Jan-Feb;33(1):1-5. doi: 10.1016/j.amjoto.2010.11.011. Epub 2011 Feb 8.
citation: Chiang FY, Lu IC, Tsai CJ, Hsiao PJ, Hsu CC, Wu CW. Does extensive dissection of recurrent laryngeal nerve during thyroid operation increase the risk of nerve injury? Evidence from the application of intraoperative neuromonitoring. Am J Otolaryngol. 2011 Nov-Dec;32(6):499-503. doi: 10.1016/j.amjoto.2010.11.001. Epub 2011 Feb 8.
citation: Chiang FY, Lu IC, Chen HC, Chen HY, Tsai CJ, Lee KW, Hsiao PJ, Wu CW. Intraoperative neuromonitoring for early localization and identification of recurrent laryngeal nerve during thyroid surgery. Kaohsiung J Med Sci. 2010 Dec;26(12):633-9. doi: 10.1016/S1607-551X(10)70097-8.
citation: Chiang FY, Lu IC, Kuo WR, Lee KW, Chang NC, Wu CW. The mechanism of recurrent laryngeal nerve injury during thyroid surgery--the application of intraoperative neuromonitoring. Surgery. 2008 Jun;143(6):743-9. doi: 10.1016/j.surg.2008.02.006.