Effect of IONM on Efficacy and Safety Using Sugammadex in Thyroid Surgery

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03634956
• Other study ID #: BakirköyEAH 1
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: March 14, 2019

Study information

• Verified date: August 2018
• Source: Lütfiye Nuri Burat Government Hospital
• Contact: Turgut Donmez, surgeon
• Phone: +905347400967
• Email: surgeont73[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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),

Related Conditions & MeSH terms

• Paralysis
• Recurrent Laryngeal Nerve
• Vocal Cord Paralysis

Intervention

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

Locations

Country	Name	City	State
Turkey	Lutfiye NBGH	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Lütfiye Nuri Burat Government Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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

Outcome

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