BABA Robotic Thyroidectomy Without Gas is Safe Enough as That Use a Gas

Study Overview
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Brief Summary
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In this study, a randomized controlled study was conducted between two groups of 14 classic recipients of Carbon dioxide insufflation during BABA robotic-thyroidectomy and 14 recipients of Gasless method during BABA robotic-thyroidectomy. This is a study to see if there is any difference in hemodynamic and metabolic changes and pain .

Official Title
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A Prospective, Randomized, and Controlled Study of the Safety and Efficacy in Gasless BABA(Bilateral Axillo-breast Approach) Robotic Thyroidectomy

Conditions
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Thyroidectomy, Thyroid Diseases

Intervention / Treatment
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* Procedure: Gasless BABA
* Procedure: Classic BABA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject who will have thyroid surgery Exclusion Criteria: Subject who underwent thyroid surgery Subject who underwent any radiotherapy on neck Subject who need to neck dissection Subject under 18 years or over 70 years Bad general condition High American Society of Anesthesiologists(ASA) score (over 3) Breast feeder or pregnancy Subject who disagree to do this trial

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gasless BABA<br>BABA robotic-thyroidectomy that do not using carbon dioxide but using elevation of flap. | Procedure: Gasless BABA<br>* BABA robotic-thyroidectomy that is using elevation of flap instead of using carbon dioxide.<br>|
| Active Comparator: Classic BABA<br>BABA robotic-thyroidectomy using carbon dioxide. | Procedure: Classic BABA<br>* BABA robotic-thyroidectomy that is using carbon dioxide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | heart rate in beats per minute | Change from baseline heart rate at the end of surgery | 
| mean arterial pressure | mean arterial pressure in mmHg | Change from baseline mean arterial pressure at the end of surgery | 
| cardiac index | cardiac index in L/min/m^2, divide the cardiac output by the person's body surface area, measured by the Vigileo monitor, normal range is 2.5 to 4.5L/min/m2 | Change from baseline cardiac index at the end of surgery | 
| cardiac output | cardiac output in L/minute, calculated by multiplying the stroke volume by the heart rate, measured by the Vigileo monitor | Change from baseline cardiac output at the end of surgery | 
| pH | pH | Change from baseline pH at the end of surgery | 
| PaCO2 | PaCO2 in mmHg | Change from baseline PaCO2 at the end of surgery | 
| VAS(visual analog score) | Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains | change from baseline VAS up to 3days after surgery | 
| BHC(bottom hit count) | bottom hit count from intravenous patient controlled analgesia for pain | change from baseline BHC up to 3days after surgery | 
| number of analgesics | number of analgesics(additional ketorolac uses) | change from baseline number of analgesics up to 3days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gasless, Bilateral axillo-breast approach, Da Vinci, Robot-assisted thyroid surgery