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

Thyroid Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922282
• Other study ID #: 2017-08-009-004
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: October 8, 2018

Study information

• Verified date: April 2019
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 8, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroidectomy

Intervention

Procedure:
• Gasless BABA
BABA robotic-thyroidectomy that is using elevation of flap instead of using carbon dioxide.
• Classic BABA
BABA robotic-thyroidectomy that is using carbon dioxide.

Locations

Country	Name	City	State
Korea, Republic of	Dong sik Bae	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate	heart rate in beats per minute	Change from baseline heart rate at the end of surgery
Primary	mean arterial pressure	mean arterial pressure in mmHg	Change from baseline mean arterial pressure at the end of surgery
Primary	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
Primary	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
Primary	pH	pH	Change from baseline pH at the end of surgery
Primary	PaCO2	PaCO2 in mmHg	Change from baseline PaCO2 at the end of surgery
Primary	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
Primary	BHC(bottom hit count)	bottom hit count from intravenous patient controlled analgesia for pain	change from baseline BHC up to 3days after surgery
Primary	number of analgesics	number of analgesics(additional ketorolac uses)	change from baseline number of analgesics up to 3days after surgery