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

Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity in Patients Undergoing Major Abdominal Cancer Surgeries

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03024957
Enrollment
30
Registered
2017-01-19
Start date
2017-01-31
Completion date
2021-02-28
Last updated
2021-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune System Suppression

Keywords

morphine, dexmedetomidine, immune system

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.

Interventions

DRUGMorphine Sulfate

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 .

DRUGDexmedetomidine

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.

DRUGBupivacaine

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from the base line in cellular immunityBaseline , immediate postoperative, 4 hours postoperative and 24 hours postoperativeCD3, CD4, CD4/CD8, CD16, CD56

Secondary

MeasureTime frameDescription
Change from baseline in CytokinesBaseline, immediate postoperative, 4 hours postoperative and 24 hours postoperativeinterleukin-1B, interleukin-6, interleukin-10 and tumor necrosis factor

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026