Effects of Intrathecally Administered Ketamine, Morphine and Their Combination in Patients Undergoing Major Abdominal Cancer Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Visual Analogue Scale (VAS) scores
研究概览
简要总结
this study investigates the analgesic efficacy and other possible effects of ketamine, morphine, and both together when administered intrathecally for control of postoperative pain following lower abdominal cancer surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesia (ASA) I-III patients.
- •aged 30-50 years.
- •scheduled for major abdominal cancer surgery.
排除标准
- •Patients with a known allergy to the study drugs.
- •significant cardiac, respiratory, renal or hepatic disease.
- •coagulation disorders.
- •infection at or near the site of intrathecal injection.
- •drug or alcohol abuse.
- •BMI > 30 kg/m
- •psychiatric illnesses that may interfere with perception and assessment of pain.
研究组 & 干预措施
group I: morphine group
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine in 1 ml volume intrathecally.
干预措施: intrathecal morphine (Drug)
group II: ketamine group
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume intrathecally.
干预措施: intrathecal ketamine (Drug)
group III: morphine + ketamine group
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine plus 0.1 mg/kg of Ketamine in 1 ml volume intrathecally.
干预措施: intrathecal morphine + ketamine (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS) scores
时间窗: 24 hours postoperative
postoperative pain measured by this score.
time to first analgesic request
时间窗: 24 hours postoperative
the time passed till the first request of rescue analgesia by the patients
total analgesic consumption
时间窗: 24 hours postoperative
the total amount of rescue analgesic drug used allover follow up period
次要结局
- side effects(24 hours postoperative)
研究者
Ahmad Mohammad Abd El-Rahman
Lecturer of anesthesia, icu, and pain management
Assiut University