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Effect of Morphine, Tramadol, and Ketorolac on Postoperative Stress and Immune Responses

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ClinicalTrials.gov Identifier: NCT02449954
Recruitment Status : Unknown
Verified May 2015 by Ahmad Mohammad Abd El-Rahman, Assiut University.
Recruitment status was:  Active, not recruiting
First Posted : May 21, 2015
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Ahmad Mohammad Abd El-Rahman, Assiut University

Brief Summary:
Comparison between the effects of intravenous morphine, tramadol and ketorolac on stress and immune responses in patients undergoing modified radical mastectomy

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Intravenous morphine sulphate Drug: Intravenous tramadol HCL Drug: Intravenous ketorolac tromethamine Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison Between the Effects of Intravenous Morphine, Tramadol and Ketorolac on Stress and Immune Responses in Patients Undergoing Modified Radical Mastectomy
Study Start Date : June 2014
Actual Primary Completion Date : April 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Active Comparator: morphine group
intravenous 0.1mg/kg morphine
Drug: Intravenous morphine sulphate
Group I:received IV 0.1mg/kg morphine sulphate.
Other Name: venous blood samples

Active Comparator: tramadol group
intravenous 2 mg/kg tramadol
Drug: Intravenous tramadol HCL
Group II:received IV 2 mg/kg tramadol HCL.
Other Name: venous blood samples

Active Comparator: ketorolac group
intravenous30 mg ketorolac
Drug: Intravenous ketorolac tromethamine
Group III: received IV 30 mg ketorolac tromethamine
Other Name: venous blood samples




Primary Outcome Measures :
  1. Serum cortisol level [ Time Frame: 11 month ]
    was measure by fully automated ELISA

  2. Serum prolactin level [ Time Frame: 11 month ]
    was measure by fully automated ELISA

  3. Expression of peripheral T lymphocytes subset cluster of differentiation3 percentage(CD3+) [ Time Frame: 11 month ]
    was measured by flow cytometry

  4. Expression of peripheral T lymphocytes subset cluster of differentiation 4 percentage (CD4+) [ Time Frame: 11 month ]
    was measured by flow cytometry

  5. Expression of peripheral T lymphocytes subset cluster of differentiation 8 percentage (CD8+) [ Time Frame: 11 month ]
    was measured by flow cytometry

  6. Expressions of peripheral T lymphocytes subset cluster of differentiation56 percentage (CD56+) [ Time Frame: 11 month ]
    was measured by flow cytometry



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged (20-60 years)
  • weighting (50 -75 Kg),
  • with American Society of Anesthesiologists (ASA) physical status I or II

Exclusion Criteria:

  • Patients with known allergy to opioids or NSAIDS,
  • gastric or duodenal ulcer, on radiotherapy or chemotherapy
  • received blood transfusion before the surgery or preoperative NSAIDs, steroid or opioid medications 48 hours prior to operation

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Responsible Party: Ahmad Mohammad Abd El-Rahman, Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT02449954     History of Changes
Other Study ID Numbers: 43
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015

Keywords provided by Ahmad Mohammad Abd El-Rahman, Assiut University:
Stress and Immune Responses
morphine
tramadol
ketorolac

Additional relevant MeSH terms:
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Tramadol
Morphine
Ketorolac
Ketorolac Tromethamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action