Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity in Patients Undergoing Major Abdominal Cancer Surgeries
Overview
- Phase
- Phase 1
- Intervention
- Dexmedetomidine
- Conditions
- Immune System Suppression
- Sponsor
- Assiut University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change from the base line in cellular immunity
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Shereen Mamdouh
Lecturer of anesthesia, ICU and pain managment
Assiut University
Eligibility Criteria
Inclusion Criteria
- •ASA I-II patients scheduled for major abdominal cancer surgeries
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Dexmedetomidine
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.
Intervention: Bupivacaine
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.
Intervention: Morphine Sulfate
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.
Intervention: Bupivacaine
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.
Intervention: Morphine Sulfate
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.
Intervention: Dexmedetomidine
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.
Intervention: Bupivacaine
Outcomes
Primary Outcomes
Change from the base line in cellular immunity
Time Frame: Baseline , immediate postoperative, 4 hours postoperative and 24 hours postoperative
CD3, CD4, CD4/CD8, CD16, CD56
Secondary Outcomes
- Change from baseline in Cytokines(Baseline, immediate postoperative, 4 hours postoperative and 24 hours postoperative)