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

NCT ID: NCT03634956

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-14
• Study Completion Date: 2019-03-14

Brief 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.

Detailed 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.

Conditions

Vocal Cord Paralysis; Recurrent Laryngeal Nerve

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group I.IONM in thyroid surgery

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.

Group Type: EXPERIMENTAL

Group B. Sugammadex sodium-IONM

Intervention Type: DRUG

Group B.the vagal nerve is detected and then 2 mg / kg of sugammadex sodium is administered to remove the muscle relaxant effect

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Sugammadex sodium intervention group

Eligibility Criteria

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),

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lütfiye Nuri Burat Government Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

TURGUT DONMEZ

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Turgut Donmez, surgeon

Role: PRINCIPAL_INVESTIGATOR

Lütfiye Nuri Burat Goverment Hastanesi

Locations

Lutfiye NBGH

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Turgut Donmez, surgeon

Role: CONTACT

surgeont73@hotmail.com

+905347400967

Mehmet Emin Gunes, surgeon

Role: CONTACT

memgunes@hotmail.com

+90532 59943334

Facility Contacts

Turgut Donmez, MD

Role: primary

surgeont73@hotmail.com

00905347400967

References

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.

Reference Type: BACKGROUND

PMID: 28349321 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19177420 (View on PubMed)

Other Identifiers

BakirköyEAH 1

Identifier Type: -

Identifier Source: org_study_id