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

Not Applicable

Completed

• Conditions: Thyroidectomy; Thyroid Diseases
• Interventions: Procedure: Gasless BABA; Procedure: Classic BABA

• Registration Number: NCT03922282
• Lead Sponsor: Inje University

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-03
• Primary Completion: 2018-08-31
• Study Completion: 2018-10-08
• Study First Submitted: 2019-02-20
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-18
• Last Update Submitted: 2019-04-18
• Study First Posted: 2019-04-19
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gasless BABA	Gasless BABA	BABA robotic-thyroidectomy that do not using carbon dioxide but using elevation of flap.
Classic BABA	Classic BABA	BABA robotic-thyroidectomy using carbon dioxide.

Primary Outcome Measures

Name	Time	Method
mean arterial pressure	Change from baseline mean arterial pressure at the end of surgery	mean arterial pressure in mmHg
pH	Change from baseline pH at the end of surgery	pH
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)
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
PaCO2	Change from baseline PaCO2 at the end of surgery	PaCO2 in mmHg
heart rate	Change from baseline heart rate at the end of surgery	heart rate in beats per minute

Trial Locations

Locations (1)

Dong sik Bae; 🇰🇷 Busan, Korea, Republic of