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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03922282
Other study ID # 2017-08-009-004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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