Effectiveness of Two-channel Intravenous Patient-controlled Analgesia With Dexmedetomidine on Postoperative Opioid Consumption After Major Laparoscopic Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Fentanyl consumption during 24 hours
研究概览
简要总结
Dexmedetomidine was administered in the 'selector' channel and fentanyl in the 'basic & bolus' channel of dual channel intravenous patient-controlled analgesia (IV-PCA) and the amount of opioid consumption was compared. In addition, intensity of pain, postoperative nausea/vomiting, and postoperative delirium was evaluated.
详细描述
Bellomic® (Cebika, Uiwang-si, Gyeonggi-do, South Korea), a new IV-PCA device consisting of two separate drug pump channels, can be used in various ways and is expanding its scope of use. Unlike conventional IV-PCA devices, which have been used to mix and administer all drugs in one channel, the device can inject drugs separately in two channels. One channel (Selector & Bolus) allows the patient to control whether to take additional bolus medication by pressing the button with adjustable continuous infusion, while the other channel (Continuous) allows constant rate continuous infusion.
Dexmedetomidine is a selective alpha-2 agonist, which is widely used in intensive care unit management, surgery, and various procedures because it has the advantage of less respiratory suppression along with sedation/anesthesia and pain effects. It has been previously reported that postoperative pain, morphine usage, and nausea/vomiting can be reduced when used during/after surgery in addition to general anesthetic drugs. However, in terms of major abdominal surgery, there is no research related to the use of dexmedetomidine after surgery, even though a large amount of opioid agents are required due to severe acute pain.
Thus, the investigators planned a randomized controlled trial to investigate the effectiveness dexmedetomidine using dual-chamber IV-PCA.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who was scheduled for laparoscopic major abdominal surgery (Gastrectomy, Hepatectomy, Colectomy, Pancreatectomy) under general anesthesia
- •Aged ≥ 20 years old
排除标准
- •Body mass index ≥35 kg/m2
- •American Society of Anesthesiologists physical status > 3
- •Severe cardiovascular disorder
- •Severe liver or renal dysfunction
- •Preoperative dyspnea
- •Contraindication to dexmedetomidine (preoperative severe bradycardia (Heart rate <50), atrioventricular block, allergy to dexmedetomidine)
- •Preoperative use of opioid, anticonvulsant, antidepressant
研究组 & 干预措施
Control group
Continuous channel: normal saline 100ml, 2ml/h (fixed rate) Selector & Bolus channel: fentanyl 20mcg/kg (Total 50ml with normal saline), bolus 1ml/10min lock-out
干预措施: Control (Drug)
Dexmedetomidine group
Continuous channel: dexmedetomidine 10mcg/kg (Total 100ml with normal saline), 2ml/h (fixed rate) Selector & Bolus channel: fentanyl 20mcg/kg (Total 50ml with normal saline), bolus 1ml/10min lock-out
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Fentanyl consumption during 24 hours
时间窗: 24 hours after surgery
Cumulative consumption of fentanyl during 24 hours
次要结局
- Additional analgesic consumption at post-anesthesia care unit(1 hour after surgery)
- Adverse events during 1,6,24,48 hours(1,6,24,48 hours after surgery)
- Rescue analgesic consumption at 1,6,24,48 hours(1,6,24,48 hours after surgery)
- Satisfaction score at 24 hours(24 hours after surgery)
- Fentanyl consumption during 1,6,48 hours(1,6,24,48 hours after surgery)
- Pain scores at 1,6,24,48 hours(1,6,24,48 hours after surgery)
- Delirium during 1,6,24,48 hours(1,6,24,48 hours after surgery)
研究者
Seok Kyeong Oh
Associate Professor
Korea University Guro Hospital