Thyroid Diseases, Thyroidectomy
Conditions
Keywords
Gasless, Bilateral axillo-breast approach, Da Vinci, Robot-assisted thyroid surgery
Brief summary
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 .
Interventions
PROCEDUREGasless BABA
BABA robotic-thyroidectomy that is using elevation of flap instead of using carbon dioxide.
PROCEDUREClassic BABA
BABA robotic-thyroidectomy that is using carbon dioxide.
Sponsors
Inje University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| heart rate | Change from baseline heart rate at the end of surgery | heart rate in beats per minute |
| mean arterial pressure | Change from baseline mean arterial pressure at the end of surgery | mean arterial pressure in mmHg |
| cardiac index | Change from baseline cardiac index at the end of surgery | 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 |
| cardiac output | Change from baseline cardiac output at the end of surgery | cardiac output in L/minute, calculated by multiplying the stroke volume by the heart rate, measured by the Vigileo monitor |
| pH | Change from baseline pH at the end of surgery | pH |
| PaCO2 | Change from baseline PaCO2 at the end of surgery | PaCO2 in mmHg |
| VAS(visual analog score) | change from baseline VAS up to 3days after surgery | Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains |
| BHC(bottom hit count) | change from baseline BHC up to 3days after surgery | bottom hit count from intravenous patient controlled analgesia for pain |
| number of analgesics | change from baseline number of analgesics up to 3days after surgery | number of analgesics(additional ketorolac uses) |
Countries
South Korea
Outcome results
None listed