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

A

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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