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

Assiut University30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Immune System Suppression

Interventions

Morphine SulfateDRUG

Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces with injection of morphine sulphate .

DexmedetomidineDRUG

Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces.

BupivacaineDRUG

Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Assiut University

Asyut, Egypt

Outcomes

Primary Outcomes

Change from the base line in cellular immunity

CD3, CD4, CD4/CD8, CD16, CD56

Time frame: Baseline , immediate postoperative, 4 hours postoperative and 24 hours postoperative

Secondary Outcomes

Change from baseline in Cytokines

interleukin-1B, interleukin-6, interleukin-10 and tumor necrosis factor

Time frame: Baseline, immediate postoperative, 4 hours postoperative and 24 hours postoperative

Data from ClinicalTrials.gov

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