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

Immune System Suppression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03024957
• Other study ID #: 123
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: January 2017
• Est. completion date: February 2021

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: February 2021
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune System Suppression

Intervention

Drug:
• Morphine 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 .
• Dexmedetomidine
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.
• Bupivacaine
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.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the base line in cellular immunity	CD3, CD4, CD4/CD8, CD16, CD56	Baseline , immediate postoperative, 4 hours postoperative and 24 hours postoperative
Secondary	Change from baseline in Cytokines	interleukin-1B, interleukin-6, interleukin-10 and tumor necrosis factor	Baseline, immediate postoperative, 4 hours postoperative and 24 hours postoperative