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Completed

NCT Number: NCT03922282

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

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 .

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Key information

Conditions

Thyroidectomy Endocrine System Diseases Thyroid Diseases

Age range

19 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dong sik Bae

Busan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gasless BABA

Procedure

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

Classic BABA

Procedure

BABA robotic-thyroidectomy that is using carbon dioxide.

Primary outcomes

  1. heart rate

    Time frame: Change from baseline heart rate at the end of surgery

    heart rate in beats per minute

  2. mean arterial pressure

    Time frame: Change from baseline mean arterial pressure at the end of surgery

    mean arterial pressure in mmHg

  3. 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

  4. 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

  5. pH

    Time frame: Change from baseline pH at the end of surgery

    pH

  6. PaCO2

    Time frame: Change from baseline PaCO2 at the end of surgery

    PaCO2 in mmHg

  7. 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

  8. 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

  9. number of analgesics

    Time frame: change from baseline number of analgesics up to 3days after surgery

    number of analgesics(additional ketorolac uses)

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2019
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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