Effect of IONM on Efficacy and Safety Using Sugammadex in Thyroid Surgery
Primary Purpose
Vocal Cord Paralysis, Recurrent Laryngeal Nerve
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group B. Sugammadex sodium-IONM
Sponsored by
About this trial
This is an interventional prevention trial for Vocal Cord Paralysis focused on measuring multinoduler goitre, thyroid cancer, sugammadex sodium, intraoperative nerve monitorization
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),
Sites / Locations
- Lutfiye NBGHRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group I.IONM in thyroid surgery
Arm Description
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.
Outcomes
Primary Outcome Measures
Vocal cord paralysis
postoperative vocal cord examination will be performed and the recurrent laryngeal nerve will be examined.
Secondary Outcome Measures
vagal nerve conduction value(V1)
V1: value to receive enough nerve conduction for IONM use from the vagus nerve
vagal nerve conduction value after lob resection(V2)
V2:Vagus value after resection of thyroid lobe
first detected vagal nerve conduction value(V0)
initial value after vagus sinus is detected
TOF time
the time that the muscle relaxant is shown by the peripheral nerve stimulator whose effect has disappeared.TOF>0.9
Full Information
NCT ID
NCT03634956
First Posted
August 13, 2018
Last Updated
August 16, 2018
Sponsor
Lütfiye Nuri Burat Government Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03634956
Brief Title
Effect of IONM on Efficacy and Safety Using Sugammadex in Thyroid Surgery
Official Title
Reversal of Rocuronium-Induced Neuromuscular Blockade by Sugammadex Increase for Efficiency of Intraoperative Neural Monitoring in the Thyroid Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
February 14, 2019 (Anticipated)
Study Completion Date
March 14, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lütfiye Nuri Burat Government Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Cord Paralysis, Recurrent Laryngeal Nerve
Keywords
multinoduler goitre, thyroid cancer, sugammadex sodium, intraoperative nerve monitorization
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Group A. Sugammadex sodium-IONM in thyroid surgery Group B.Standart technique-IONM in thyroid surgery
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I.IONM in thyroid surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Group B. Sugammadex sodium-IONM
Other Intervention Name(s)
Sugammadex sodium intervention group
Intervention Description
Group B.the vagal nerve is detected and then 2 mg / kg of sugammadex sodium is administered to remove the muscle relaxant effect
Primary Outcome Measure Information:
Title
Vocal cord paralysis
Description
postoperative vocal cord examination will be performed and the recurrent laryngeal nerve will be examined.
Time Frame
postop 15th days
Secondary Outcome Measure Information:
Title
vagal nerve conduction value(V1)
Description
V1: value to receive enough nerve conduction for IONM use from the vagus nerve
Time Frame
15 to 45 minutes of surgery
Title
vagal nerve conduction value after lob resection(V2)
Description
V2:Vagus value after resection of thyroid lobe
Time Frame
30 to 90 minutes of surgery
Title
first detected vagal nerve conduction value(V0)
Description
initial value after vagus sinus is detected
Time Frame
5 to 25 minutes of surgery
Title
TOF time
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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),
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Turgut Donmez, surgeon
Phone
+905347400967
Email
surgeont73@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet Emin Gunes, surgeon
Phone
+90532 59943334
Email
memgunes@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Turgut Donmez, surgeon
Organizational Affiliation
Lütfiye Nuri Burat Goverment Hastanesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lutfiye NBGH
City
İstanbul
ZIP/Postal Code
34300
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Turgut Donmez, MD
Phone
00905347400967
Email
surgeont73@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
14.08.2018-14.02.2019
IPD Sharing Access Criteria
the study data will be stored securely on the researcher's turgut donmez personal computer. It will be available to researchers participating in the study alone
Citations:
PubMed Identifier
28349321
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.
Results Reference
background
PubMed Identifier
19177420
Citation
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.
Results Reference
background
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Effect of IONM on Efficacy and Safety Using Sugammadex in Thyroid Surgery
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