Vocal Cord Paralysis Clinical Trial
Official title:
Reversal of Rocuronium-Induced Neuromuscular Blockade by Sugammadex Increase for Efficiency of Intraoperative Neural Monitoring in the Thyroid Surgery
Thyroidectomy is a frequently performed surgeon by the head and neck and endocrine surgeons. In recent years, surgical techniques and technological developments have resulted in a significant reduction in complication rates. Despite these advances, there is still a great deal of anxiety about the sound problems that can be experienced in patients after surgery. In the past years,the investigators have tried to prevent recurrent nerve paralysis by using intraoperative nerve monitoring (IONM). The use of IONM has begun to be preferred by many surgeons in the investigator's country. However, the use of IONM decreases the number of recurrent nerve paralysis are still being discussed and many studies have been done. In this study, it is aimed to prevent the formation of recurrent nerve paralysis in order to safely carry out the IONM by removing the effects of neuromuscular blockade drugs using sugammadex sodium medicine in the thyroidectomy operations.
Status | Recruiting |
Enrollment | 2 |
Est. completion date | March 14, 2019 |
Est. primary completion date | February 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of Multinodular goiter, - Clinical diagnosis of thyroid cancer - Clinical diagnosis of noduler goatr, - Clinical diagnosis of basedow Graves disease, Exclusion Criteria: - Patients with bleeding diathesis, - Patients who have previously undergone laryngeal surgery (vocal polyps, nodules or laryngeal cancer), |
Country | Name | City | State |
---|---|---|---|
Turkey | Lutfiye NBGH | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Lütfiye Nuri Burat Government Hospital |
Turkey,
Barczynski M, Konturek A, Cichon S. Randomized clinical trial of visualization versus neuromonitoring of recurrent laryngeal nerves during thyroidectomy. Br J Surg. 2009 Mar;96(3):240-6. doi: 10.1002/bjs.6417. — View Citation
Empis de Vendin O, Schmartz D, Brunaud L, Fuchs-Buder T. Recurrent Laryngeal Nerve Monitoring and Rocuronium: A Selective Sugammadex Reversal Protocol. World J Surg. 2017 Sep;41(9):2298-2303. doi: 10.1007/s00268-017-4004-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vocal cord paralysis | postoperative vocal cord examination will be performed and the recurrent laryngeal nerve will be examined. | postop 15th days | |
Secondary | vagal nerve conduction value(V1) | V1: value to receive enough nerve conduction for IONM use from the vagus nerve | 15 to 45 minutes of surgery | |
Secondary | vagal nerve conduction value after lob resection(V2) | V2:Vagus value after resection of thyroid lobe | 30 to 90 minutes of surgery | |
Secondary | first detected vagal nerve conduction value(V0) | initial value after vagus sinus is detected | 5 to 25 minutes of surgery | |
Secondary | TOF time | the time that the muscle relaxant is shown by the peripheral nerve stimulator whose effect has disappeared.TOF>0.9 | 10 to 90 minutes of surgery |
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