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

NCT03922282 | Completed

• 1 other identifier: 2017-08-009-004
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 .

Conditions

Thyroidectomy; Thyroid Diseases

Keywords

Gasless; Bilateral axillo-breast approach; Da Vinci; Robot-assisted thyroid surgery

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Gasless BABA

EXPERIMENTAL

BABA robotic-thyroidectomy that do not using carbon dioxide but using elevation of flap.

Procedure: Gasless BABA

Classic BABA

ACTIVE COMPARATOR

BABA robotic-thyroidectomy using carbon dioxide.

Procedure: Classic BABA

Interventions

Gasless BABA PROCEDURE

BABA robotic-thyroidectomy that is using elevation of flap instead of using carbon dioxide.

Gasless BABA

Classic BABA PROCEDURE

BABA robotic-thyroidectomy that is using carbon dioxide.

Classic BABA

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject who will have thyroid surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Inje University: lead

Study Sites (1)

Dong sik Bae

Busan, South Korea

Location

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: April 19, 2019
• Study Start: January 3, 2018
• Primary Completion: August 31, 2018
• Study Completion: October 8, 2018
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

KR (1)