The Optimal Dosage of Rocuronium for Intraoperative Neuromonitoring During Thyroid Surgery
IONM
The Optimal Dosage of Neuromuscular Blocking Agent for Intraoperative Neuromonitoring During Thyroid Surgery
1 other identifier
observational
80
1 country
1
Brief Summary
The investigators tried to explore an alternative non-depolarizing muscle relaxant (rocuronium) and its optimal dosage to replace succinylcholine for IONM during thyroid surgery.Time frame of outcome measure was during 30 to 70min after rocuronium injection. Specific time points at which the will be assessed and for EMG signals will be presented.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 8, 2010
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedMarch 4, 2015
February 1, 2015
11 months
July 8, 2010
February 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The time to detect V1 and V2 signals
V1 signal means an EMG signals obtained from the vagus nerve before identification of RLN. V2 signal-The final testing of the vagus nerve EMG signals was performed after complete hemostasis of the operative field. The amplitude (μV) of V1 and V2 signals and the correlated degree of neuromuscular transmission (% TW) were recorded and analyzed.
WITHIN 2 DAYS, follow up to 6 months
Eligibility Criteria
Patients who were planned to receive thyroidectomy
You may qualify if:
- Clinical diagnosis of thyroid tumor
You may not qualify if:
- neuromuscular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Medical University Chung-Ho Hospital
Kaohsiung City, 807, Taiwan
Related Publications (3)
Dralle H, Sekulla C, Lorenz K, Brauckhoff M, Machens A; German IONM Study Group. Intraoperative monitoring of the recurrent laryngeal nerve in thyroid surgery. World J Surg. 2008 Jul;32(7):1358-66. doi: 10.1007/s00268-008-9483-2.
PMID: 18305996BACKGROUNDChan WF, Lo CY. Pitfalls of intraoperative neuromonitoring for predicting postoperative recurrent laryngeal nerve function during thyroidectomy. World J Surg. 2006 May;30(5):806-12. doi: 10.1007/s00268-005-0355-8.
PMID: 16680596BACKGROUNDChan WF, Lang BH, Lo CY. The role of intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy: a comparative study on 1000 nerves at risk. Surgery. 2006 Dec;140(6):866-72; discussion 872-3. doi: 10.1016/j.surg.2006.07.017. Epub 2006 Sep 18.
PMID: 17188132BACKGROUND
Study Officials
- STUDY CHAIR
I-Chen Lu, M.D.
Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- visiting staff
Study Record Dates
First Submitted
July 8, 2010
First Posted
March 4, 2015
Study Start
January 1, 2009
Primary Completion
December 1, 2009
Study Completion
February 1, 2010
Last Updated
March 4, 2015
Record last verified: 2015-02