Effect of Morphine, Tramadol, and Ketorolac on Postoperative Stress and Immune Responses
Comparison Between the Effects of Intravenous Morphine, Tramadol and Ketorolac on Stress and Immune Responses in Patients Undergoing Modified Radical Mastectomy
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Comparison between the effects of intravenous morphine, tramadol and ketorolac on stress and immune responses in patients undergoing modified radical mastectomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Jun 2014
Shorter than P25 for phase_2 breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 29, 2015
CompletedFirst Posted
Study publicly available on registry
May 21, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMay 21, 2015
May 1, 2015
10 months
April 29, 2015
May 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Serum cortisol level
was measure by fully automated ELISA
11 month
Serum prolactin level
was measure by fully automated ELISA
11 month
Expression of peripheral T lymphocytes subset cluster of differentiation3 percentage(CD3+)
was measured by flow cytometry
11 month
Expression of peripheral T lymphocytes subset cluster of differentiation 4 percentage (CD4+)
was measured by flow cytometry
11 month
Expression of peripheral T lymphocytes subset cluster of differentiation 8 percentage (CD8+)
was measured by flow cytometry
11 month
Expressions of peripheral T lymphocytes subset cluster of differentiation56 percentage (CD56+)
was measured by flow cytometry
11 month
Study Arms (3)
morphine group
ACTIVE COMPARATORintravenous 0.1mg/kg morphine
tramadol group
ACTIVE COMPARATORintravenous 2 mg/kg tramadol
ketorolac group
ACTIVE COMPARATORintravenous30 mg ketorolac
Interventions
Group I:received IV 0.1mg/kg morphine sulphate.
Group II:received IV 2 mg/kg tramadol HCL.
Group III: received IV 30 mg ketorolac tromethamine
Eligibility Criteria
You may qualify if:
- patients aged (20-60 years)
- weighting (50 -75 Kg),
- with American Society of Anesthesiologists (ASA) physical status I or II
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
April 29, 2015
First Posted
May 21, 2015
Study Start
June 1, 2014
Primary Completion
April 1, 2015
Study Completion
June 1, 2015
Last Updated
May 21, 2015
Record last verified: 2015-05