A Prospective, Randomized, and Controlled Study of the Safety and Efficacy in Gasless BABA(Bilateral Axillo-breast Approach) Robotic Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- mean arterial pressure
研究概览
简要总结
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who will have thyroid surgery
排除标准
- •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
研究组 & 干预措施
Gasless BABA
BABA robotic-thyroidectomy that do not using carbon dioxide but using elevation of flap.
干预措施: Gasless BABA (Procedure)
Classic BABA
BABA robotic-thyroidectomy using carbon dioxide.
干预措施: Classic BABA (Procedure)
结局指标
主要结局
mean arterial pressure
时间窗: Change from baseline mean arterial pressure at the end of surgery
mean arterial pressure in mmHg
pH
时间窗: Change from baseline pH at the end of surgery
pH
VAS(visual analog score)
时间窗: 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)
时间窗: change from baseline BHC up to 3days after surgery
bottom hit count from intravenous patient controlled analgesia for pain
number of analgesics
时间窗: change from baseline number of analgesics up to 3days after surgery
number of analgesics(additional ketorolac uses)
cardiac index
时间窗: 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
时间窗: 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
时间窗: Change from baseline PaCO2 at the end of surgery
PaCO2 in mmHg
heart rate
时间窗: Change from baseline heart rate at the end of surgery
heart rate in beats per minute
次要结局
未报告次要终点
研究者
Dongsik Bae
Assistant Professor
Inje University