Effect of IONM on Efficacy and Safety Using Sugammadex in Thyroid Surgery
Reversal of Rocuronium-Induced Neuromuscular Blockade by Sugammadex Increase for Efficiency of Intraoperative Neural Monitoring in the Thyroid Surgery
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2018
CompletedStudy Start
First participant enrolled
August 14, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2019
CompletedAugust 20, 2018
August 1, 2018
6 months
August 13, 2018
August 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vocal cord paralysis
postoperative vocal cord examination will be performed and the recurrent laryngeal nerve will be examined.
postop 15th days
Secondary Outcomes (4)
vagal nerve conduction value(V1)
15 to 45 minutes of surgery
vagal nerve conduction value after lob resection(V2)
30 to 90 minutes of surgery
first detected vagal nerve conduction value(V0)
5 to 25 minutes of surgery
TOF time
10 to 90 minutes of surgery
Study Arms (1)
Group I.IONM in thyroid surgery
EXPERIMENTALGroup 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.
Interventions
Group B.the vagal nerve is detected and then 2 mg / kg of sugammadex sodium is administered to remove the muscle relaxant effect
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Multinodular goiter,
- Clinical diagnosis of thyroid cancer
- Clinical diagnosis of noduler goatr,
- Clinical diagnosis of basedow Graves disease,
You may not qualify if:
- Patients with bleeding diathesis,
- Patients who have previously undergone laryngeal surgery (vocal polyps, nodules or laryngeal cancer),
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lutfiye NBGH
Istanbul, 34300, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 28349321BACKGROUNDBarczynski 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.
PMID: 19177420BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Turgut Donmez, surgeon
Lütfiye Nuri Burat Goverment Hastanesi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 13, 2018
First Posted
August 17, 2018
Study Start
August 14, 2018
Primary Completion
February 14, 2019
Study Completion
March 14, 2019
Last Updated
August 20, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 14.08.2018-14.02.2019
- 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
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.