Comparison Between Ketamine and Tramadol for Pain Management After Major Upper Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Measurement of morphine consumption expressed as milligrams postoperatively in abdominal surgery.
研究概览
简要总结
The purpose of the study is the comparison between ketamine and tramadol, regarding the analgesia quality and efficiency, in patients receiving Patient Controlled Analgesia (PCA) morphine, after major upper abdominal surgeries such as hepatectomies, gastrectomies, Whipple procedures and peripheral pancreatectomies. The goal is to bring out an improved analgesia scheme, which can be applied to the clinical work and refine the analgesia provided for major procedures which require increased postoperative opioids doses. In the study, half of patients will receive continuous intravenous infusion of tramadol and Patient Controlled Analgesia morphine and the other half will receive continuous intravenous infusion of ketamine and Patient Controlled Analgesia morphine postoperatively after major upper abdominal surgery. The successful combination of different drugs targets at the improvement of the analgesia provided, the reduction of complications and the exploitation of the pharmacodynamic properties of each drug.
详细描述
This is a single blind, prospective, randomized controlled trial. Forty two adults patients of American Society of Anesthesiologists (ASA) physical status I-II, aged 18-70yr, scheduled for elective upper abdominal surgery under general anaesthesia are recruited. Signed informed consent is obtained from all patients. Patients are randomized into two groups.
- Ketamine group: thirty minutes before the expected end of surgery, ketamine is administered IV at a load dose of 0.5mg/kg followed by a continuous infusion of ketamine (0.12mg•kg-¹•h-¹) for up to 48 h.
- Tramadol group: thirty minutes before the expected end of surgery, tramadol is administered IV at a load dose of 1mg/kg followed by a continuous infusion of tramadol (0.2mg•kg-¹•h-¹) for up to 48 h.
The evening before the elective surgery, all patients are premedicated with 150 mg ranitidine and 100mg hydroxyzine orally and provided with instructions on how to use the PCA device. They are also explained the Visual Analogue Scale (VAS: 0-10).
All participants received the same protocol of general anaesthesia. Before the induction of anaesthesia all patients received metoclopramide 10 mg, ranitidine 50 mg and dimethindene 4 mg intravenously. Anaesthesia was induced with propofol 2 mg/kg, and fentanyl 2 mcg/kg, while the administration of rocuronium facilitates the trachea intubation. The anaesthesia maintenance is attained through continuous infusion of propofol 1%. After the induction of anaesthesia and before the surgical incision, patients receive 3 mcg/kg fentanyl and 0.1mg/kg morphine intravenously, while repetitive doses of morphine 0.05 mg/kg are administered in order to keep intraoperative systolic arterial pressure and heart rate within the range of 20% of the baseline values. The total morphine consumption is recorded.
Thirty minutes before the expected end of surgery, paracetamol 1gr is administered intravenously. Consequently, patients receive either ketamine or tramadol according to the study group, at the aforementioned bolus and continuous infusions doses. The pump remained attached to the intravenous line for 48 hours.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70 years
- •American Society of Anesthesiologists (ASA) physical status I and II
- •Major Upper abdominal Surgery (Elective Hepatectomy, Gastrectomy, Whipple procedure, Peripheral Pancreatectomy)
排除标准
- •Patient's refusal to participate in the study
- •Performance of regional anaesthesia
- •Unsuitability for Patient Controlled Analgesia
- •Current opiates use
- •Drug addiction
- •Chronic Pain Syndromes
- •Alcohol addiction
- •Psychiatric disorders
- •Use of Monoamine Oxidase Inhibitor or Selective Serotonin Reuptake Inhibitor
- •Sleep Apnea Syndrome
- •Extrapyramidal Syndromes
- •Severe liver, kidney or heart disease
- •Known allergy to ketamine, tramadol or morphine.
研究组 & 干预措施
Tramadol
Intraoperative administration of a bolus dose of tramadol and continuous intravenous infusion of tramadol for up to 48 h postoperatively.
干预措施: Tramadol (Drug)
Ketamine
Intraoperative administration of a bolus dose of ketamine and continuous intravenous infusion of ketamine for up to 48 h postoperatively.
干预措施: Ketamine (Drug)
结局指标
主要结局
Measurement of morphine consumption expressed as milligrams postoperatively in abdominal surgery.
时间窗: 48 hours postoperatively
次要结局
未报告次要终点
研究者
Paraskevi Matsota
Professor of Anesthesiology, MD, PhD
Attikon Hospital