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

August 16, 2018 updated by: TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital

Reversal of Rocuronium-Induced Neuromuscular Blockade by Sugammadex Increase for Efficiency of Intraoperative Neural Monitoring in the Thyroid Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34300
        • Recruiting
        • Lutfiye NBGH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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),

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Other Names:
  • Sugammadex sodium intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vocal cord paralysis
Time Frame: postop 15th days
postoperative vocal cord examination will be performed and the recurrent laryngeal nerve will be examined.
postop 15th days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vagal nerve conduction value(V1)
Time Frame: 15 to 45 minutes of surgery
V1: value to receive enough nerve conduction for IONM use from the vagus nerve
15 to 45 minutes of surgery
vagal nerve conduction value after lob resection(V2)
Time Frame: 30 to 90 minutes of surgery
V2:Vagus value after resection of thyroid lobe
30 to 90 minutes of surgery
first detected vagal nerve conduction value(V0)
Time Frame: 5 to 25 minutes of surgery
initial value after vagus sinus is detected
5 to 25 minutes of surgery
TOF time
Time Frame: 10 to 90 minutes of surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lütfiye Nuri Burat Government Hospital

Investigators

  • Principal Investigator: Turgut Donmez, surgeon, Lütfiye Nuri Burat Goverment Hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2018

Primary Completion (Anticipated)

February 14, 2019

Study Completion (Anticipated)

March 14, 2019

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (Actual)

August 17, 2018

Study Record Updates

Last Update Posted (Actual)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BakirköyEAH 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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