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

Inje University28 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Thyroidectomy Thyroid Diseases

Interventions

Gasless BABAPROCEDURE

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

Classic BABAPROCEDURE

BABA robotic-thyroidectomy that is using carbon dioxide.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Dong sik Bae

Busan, South Korea

Outcomes

Primary Outcomes

heart rate

heart rate in beats per minute

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

mean arterial pressure

mean arterial pressure in mmHg

Time frame: 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

Time frame: 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

Time frame: Change from baseline cardiac output at the end of surgery

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

PaCO2

PaCO2 in mmHg

Time frame: 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

Time frame: change from baseline VAS up to 3days after surgery

BHC(bottom hit count)

bottom hit count from intravenous patient controlled analgesia for pain

Time frame: change from baseline BHC up to 3days after surgery

Data from ClinicalTrials.gov

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