Dexmedetomidine Versus Fentanyl Plus Bupivacaine for Epidural Analgesia With General Anesthesia for Lumbar Disc Operations
NCT ID: NCT03438240
Last Updated: 2018-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2018-02-12
2018-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group BF
Bupivacaine plus Fentanyl
Bupivacaine
patients will receive combined general anesthesia / epidural analgesia with 15 ml bupivacaine 0.20%
Fentanyl
Plus 50 µg fentanyl
Group BD
Bupivacaine plus Dexmedetomidine
Bupivacaine
patients will receive combined general anesthesia / epidural analgesia with 15 ml bupivacaine 0.20%
Dexmedetomidine
Plus 50 µg dexmedetomidine
Interventions
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Bupivacaine
patients will receive combined general anesthesia / epidural analgesia with 15 ml bupivacaine 0.20%
Fentanyl
Plus 50 µg fentanyl
Dexmedetomidine
Plus 50 µg dexmedetomidine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* First time elective lumbar dicsectomy or laminectomy
Exclusion Criteria
* Body mass index (BMI) \> 30
* Need an emergency lumbar disc operation
* ASA physical status \> II
* Major illnesses (e.g. cardiac, respiratory, renal, liver)
* Coagulation abnormalities
* Hypovolemia
* History of increased intracranial pressure
* Convulsions
* Spinal stenosis
* Infection at needle insertion site
* Other contraindications to epidural procedure
* Allergy or contraindications to the drugs used in the study
* History of addiction or alcohol abuse
* Psychiatric illness or mental retardation
20 Years
65 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Amin Mohammed Alansary Amin Ahmed Helwa
Assistant Professor
Locations
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Ain Shams University hospitals
Cairo, , Egypt
Countries
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Other Identifiers
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FMASU R8 /2018
Identifier Type: -
Identifier Source: org_study_id
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