An interventional study of Group B. Sugammadex sodium-IONM in Vocal Cord Paralysis and Recurrent Laryngeal Nerve, sponsored by Lütfiye Nuri Burat Government Hospital. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-20.
Sponsored by Lütfiye Nuri Burat Government Hospital · Not applicable, Interventional, and Prevention
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.
Patients who will undergo thyroidectomy using the IONM in the General Surgery Clinic of Istanbul, Bakırköy Dr.Sadi Konuk Training and Research Hospital. In this prospective observational clinical trial, the patients will be divided into two groups and the study will be performed as randomize. Randomization Patients who arrive consecutively, will be included in the study group (Group I IONM, group B IONM-sugammadex sodium). In both groups, anesthesia induction should be done with 3 mg / kg propofol, 2 ugr / kg fentanyl, 0.6 mg / kg rocuronium bromide, as the intubation tube, the number appropriate for the patient, After reaching the throat loom, the patient is entrapped and then the operation is started. After reaching the thyroid loin and hanging the throid with the swab sutures, the lobe is taken out with the finger maneuver and then the vascular nerve packet is dissected and the vagal nerve is exposed. IONM(Medtronic-NIM) were detected in the recurrent nerve thyroglossal groove and 100 microvolts or more were measured with nerve monitoring. + Acceptance of resection was started and IONM After the intubation of the group B-sugammadex sodium was started, the left hand ulnar sinus TOF-Guard device was placed and operation started. After reaching the thyroid loops and hanging the throids with hanging sutures and removing the lobe with finger maneuver, the vascular nerve was disassembled and the vagal nerve was dislocated. Then the electrical value was recorded with IONM and sugammadex sodium 2 mg / kg was made. and the TOF response at 4th minute is over 90% of the value to be measured and if the IONM is 100 microvolts higher, the recurrent nerve is found in the troglossal groove and the nerve is followed with the IONM and the resection procedure is started and the tirodidectomy will be performed. V0: vagal nerve initial value; V1: value before troid resection; V2: value after troid resection; R1: value after troid resection, R2: value after troid resection. Preoperative and postoperative vocal cord examination will be examined by otolaryngologist. Size, weight, sex, ASA scores, operation times, complications will be recorded. If there is no signal in RLN with intraoperative IONM and RLN paralysis will be accepted if there is inactivity in the vocal cord at the 1st postoperative ENT specialist vocal cord examinations. RLN paralysis will be accepted if there is inactivity in the cord at the vocal cord examination of the postoperative specialist ENT specialist. The ENT specialist and general surgeon will follow up and if the vocal cord is still in motion, the permanent RLN will be considered a paralysis.
55 studies on the registry are indexed under Vocal Cord Paralysis; 14 are open to participants now.
This study's planned enrollment of 2 is below the median of 39 across 38 interventional studies indexed under Vocal Cord Paralysis.
Browse Vocal Cord Paralysis studies →Lütfiye Nuri Burat Government Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Group I.IONM in thyroid surgery.Once the vagus has been detected,nerve conduction data will be detected with IONM. If the muscle relaxant effect is not detected, it will be detected with TOF device.
Drug: Group B. Sugammadex sodium-IONM
Group B.the vagal nerve is detected and then 2 mg / kg of sugammadex sodium is administered to remove the muscle relaxant effect
Also known as: Sugammadex sodium intervention group
Vocal cord paralysis
postoperative vocal cord examination will be performed and the recurrent laryngeal nerve will be examined.
Time frame: postop 15th days
vagal nerve conduction value(V1)
V1: value to receive enough nerve conduction for IONM use from the vagus nerve
Time frame: 15 to 45 minutes of surgery
vagal nerve conduction value after lob resection(V2)
V2:Vagus value after resection of thyroid lobe
Time frame: 30 to 90 minutes of surgery
first detected vagal nerve conduction value(V0)
initial value after vagus sinus is detected
Time frame: 5 to 25 minutes of surgery
TOF time
the time that the muscle relaxant is shown by the peripheral nerve stimulator whose effect has disappeared.TOF\>0.9
Time frame: 10 to 90 minutes of surgery
Plan to share: Yes — Patients who are accepted to participate in the study will be gathered in the pool. The patients' data will be entered on the computer. The computer and patients will be randomized and set up on the day of surgery. The preop, perop and postop data of the patients will be recorded on the computer.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Lütfiye Nuri Burat Government Hospital