BABA Robotic Thyroidectomy Without Gas is Safe Enough as That Use a Gas
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|ClinicalTrials.gov Identifier: NCT03922282|
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thyroidectomy Thyroid Diseases||Procedure: Gasless BABA Procedure: Classic BABA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective, Randomized, and Controlled Study of the Safety and Efficacy in Gasless BABA(Bilateral Axillo-breast Approach) Robotic Thyroidectomy|
|Actual Study Start Date :||January 3, 2018|
|Actual Primary Completion Date :||August 31, 2018|
|Actual Study Completion Date :||October 8, 2018|
Experimental: Gasless BABA
BABA robotic-thyroidectomy that do not using carbon dioxide but using elevation of flap.
Procedure: Gasless BABA
BABA robotic-thyroidectomy that is using elevation of flap instead of using carbon dioxide.
Active Comparator: Classic BABA
BABA robotic-thyroidectomy using carbon dioxide.
Procedure: Classic BABA
BABA robotic-thyroidectomy that is using carbon dioxide.
- heart rate [ Time Frame: Change from baseline heart rate at the end of surgery ]heart rate in beats per minute
- mean arterial pressure [ Time Frame: Change from baseline mean arterial pressure at the end of surgery ]mean arterial pressure in mmHg
- cardiac index [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from baseline pH at the end of surgery ]pH
- PaCO2 [ Time Frame: Change from baseline PaCO2 at the end of surgery ]PaCO2 in mmHg
- VAS(visual analog score) [ Time Frame: 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) [ Time Frame: change from baseline BHC up to 3days after surgery ]bottom hit count from intravenous patient controlled analgesia for pain
- number of analgesics [ Time Frame: change from baseline number of analgesics up to 3days after surgery ]number of analgesics(additional ketorolac uses)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922282
|Korea, Republic of|
|Dong sik Bae|
|Busan, Korea, Republic of|