Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Cardiac Index
研究概览
简要总结
The purpose of this study is to find out the effect of low abdominal pressure vs. standard abdominal pressure on the cardiac and respiratory function of the patients undergoing laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the effect of the degree of neuromuscular blockade on the surgical condition of the patients undergoing laparoscopic colon surgery in Trendelenberg position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for laparoscopic colon surgery under Trendelenberg position
排除标准
- •ASA classification IV
- •Unable to make a written, informed consent
- •Allergic to neuromuscular blocking agents, anesthetics, opioids
- •Patients with neuromuscular disease
- •Hepatic failure
- •Renal failure
- •History of malignant hyperthermia
- •Morbid obesity with BMI>35 kg/m2
- •Patients enrolled in another clinical trials
研究组 & 干预措施
CS
Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.
干预措施: Standard abdominal pressure (Device)
CS
Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.
干预措施: Conventional neuromuscular blockade (Drug)
DS
Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.
干预措施: Standard abdominal pressure (Device)
DS
Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.
干预措施: Deep neuromuscular blockade (Drug)
DL
Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.
干预措施: Low abdominal pressure (Device)
DL
Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.
干预措施: Deep neuromuscular blockade (Drug)
结局指标
主要结局
Cardiac Index
时间窗: 30 min after onset of laparoscopy
Cardiac index 30 min after onset of laparoscopy. The cardiac index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.
次要结局
- Stroke Volume Index (SVI)(1, 30, 60, 90, 120 min after onset of laparoscopy)
- PaO2(1, 30, 60, 90, and 120 minutes after onset of laparoscopy)
- Mean Arterial Blood Pressure (MBP)(1, 30, 60, 90, and 120 minutes after onset of laparoscopy)
- Pulmonary Compliance(1, 30, 60, 90, and 120 minutes after onset of laparoscopy)
- Surgical Rating Scale(1 min after laparoscopic procedure)
研究者
Kook Hyun Lee
Professor
Seoul National University Hospital