Back to resultsThe Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve
Primary Purpose
Thyroid Intra-Operative Injury
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
sugammadex
Sponsored by
About this trial
This is an interventional other trial for Thyroid Intra-Operative Injury focused on measuring intraoperative neural monitoring
Eligibility Criteria
Inclusion Criteria:
- patients undergoing intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy
Exclusion Criteria:
- Patients with a history of significant cardiac, pulmonary, hepatic, or renal disease, body mass index <18.5 or >35, chronic drug or alcohol abuse
Sites / Locations
- I-Cheng Lu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Enhanced recovery
Conventional anesthesia
Arm Description
rocuronium 2 effective dose at anesthesia induction sugammadex after skin incision and before extubation (total 2 mg/kg iv)
standard general anesthesia protocol (1 effective dose of rocuronium at anesthesia induction)
Outcomes
Primary Outcome Measures
sugammadex 2 mg/kg allows effective and rapid restoration of neuromuscular function suppressed by rocuronium
Electromyography signal to assess the quality of neuromonitoring
Secondary Outcome Measures
Full Information
NCT ID
NCT03911232
First Posted
December 5, 2016
Last Updated
June 24, 2021
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03911232
Brief Title
The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve
Official Title
The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve During Thyroid Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objectives: The use of neuromuscular blocking agent may interfere with the function of intraoperative neuromonitoring (IONM) in thyroid surgery.
Detailed Description
An enhanced neuromuscular-blockade (NMB) recovery protocol was investigated in a clinically applied during thyroid neural monitoring surgery. In as subsequent clinical application study, 60 patients who underwent thyroidectomy with IONM followed an enhanced NMB recovery protocol- rocuronium 0.6 mg/kg at anesthesia induction and sugammadex 2 mg/kg at operation start. Train-of-four (TOF) ratio was used for continuous quantitative monitoring of neuromuscular transmission.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Intra-Operative Injury
Keywords
intraoperative neural monitoring
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced recovery
Arm Type
Experimental
Arm Description
rocuronium 2 effective dose at anesthesia induction sugammadex after skin incision and before extubation (total 2 mg/kg iv)
Arm Title
Conventional anesthesia
Arm Type
No Intervention
Arm Description
standard general anesthesia protocol (1 effective dose of rocuronium at anesthesia induction)
Intervention Type
Drug
Intervention Name(s)
sugammadex
Other Intervention Name(s)
Bridion
Intervention Description
standard general anesthesia protocol with sugammadex
Primary Outcome Measure Information:
Title
sugammadex 2 mg/kg allows effective and rapid restoration of neuromuscular function suppressed by rocuronium
Description
Electromyography signal to assess the quality of neuromonitoring
Time Frame
1 month each case
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy
Exclusion Criteria:
Patients with a history of significant cardiac, pulmonary, hepatic, or renal disease, body mass index <18.5 or >35, chronic drug or alcohol abuse
Facility Information:
Facility Name
I-Cheng Lu
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve
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