Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity in Patients Undergoing Major Abdominal Cancer Surgeries
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from the base line in cellular immunity
研究概览
简要总结
this work aims to investigate the effect of intrathecal administration of Morphine, Dexmedetomidine or both in combination on cellular immunity and cytokine production in patients undergoing major abdominal cancer surgeries.
详细描述
Intrathecal (IT) adjuvants prolong the duration of spinal anesthesia and postoperative analgesia thereby reducing the requirement of postoperative supplemental analgesics. The incorporation of adjuvants also lowers the overall dose of local anesthetic and hence associated side effects. Morphine has been used widely to alleviate various types of pain and to supplement general anesthesia. On the other hand, morphine has been reported to possess some immunosuppressive effects. Postoperative immunity is also important in conjunction with defence against malignant tumour. Dexmedetomidine is a highly selective α2 agonist with analgesia, sedation, anxiolysis, and sympatholysis as its useful pharmacological actions. The extended analgesic efficacy of IT dexmedetomidine (ITD) in the postoperative period has been shown in a few clinical studies. In addition, current insights have identified that dexmedetomidine has a capacity in inhibiting the overproduction of a variety of inflammatory molecules including TNF-α, IL-1β, and IL-6 in several acute inflammatory animal models.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II patients scheduled for major abdominal cancer surgeries
排除标准
- •patients with known allergy to the study drugs,
- •significant cardiac, respiratory, renal or hepatic disease,
- •drug or alcohol abuse,
- •psychiatric illness that would interfere with perception and assessment of pain.
研究组 & 干预措施
Dexmedetomidine group
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine in 1 mL volume intrathecally.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine group
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine in 1 mL volume intrathecally.
干预措施: Bupivacaine (Drug)
Morphine group
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 0.5 mg morphine sulphate in 1 mL volume intrathecally.
干预措施: Morphine Sulfate (Drug)
Morphine group
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 0.5 mg morphine sulphate in 1 mL volume intrathecally.
干预措施: Bupivacaine (Drug)
Dexmedetomidine + morphine group
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine plus 0.5 mg of morphine sulphate in 1 mL volume intrathecally.
干预措施: Morphine Sulfate (Drug)
Dexmedetomidine + morphine group
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine plus 0.5 mg of morphine sulphate in 1 mL volume intrathecally.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine + morphine group
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine plus 0.5 mg of morphine sulphate in 1 mL volume intrathecally.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Change from the base line in cellular immunity
时间窗: Baseline , immediate postoperative, 4 hours postoperative and 24 hours postoperative
CD3, CD4, CD4/CD8, CD16, CD56
次要结局
- Change from baseline in Cytokines(Baseline, immediate postoperative, 4 hours postoperative and 24 hours postoperative)
研究者
Shereen Mamdouh
Lecturer of anesthesia, ICU and pain managment
Assiut University