Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity

Assiut University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Immune System Suppression

Treatments: Drug: Dexmedetomidine; Drug: Bupivacaine; Drug: Morphine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT03024957

123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Dexmedetomidine group

Active Comparator group

Description:

patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine in 1 mL volume intrathecally.

Treatment:

Drug: Bupivacaine

Drug: Dexmedetomidine

Morphine group

Active Comparator group

Description:

patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 0.5 mg morphine sulphate in 1 mL volume intrathecally.

Treatment:

Drug: Morphine Sulfate

Drug: Bupivacaine

Dexmedetomidine + morphine group

Active Comparator group

Description:

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.

Treatment:

Drug: Morphine Sulfate

Drug: Bupivacaine

Drug: Dexmedetomidine