Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain
NCT ID: NCT03512574
Last Updated: 2018-05-01
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
150 participants
INTERVENTIONAL
2018-01-02
2018-03-30
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 PD
combination of pregabalin and dexmedetomidine
Pregabalin and dexmedetomidine
One hour before spinal anesthesia, patients received pregabalin 150 mg orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery.
Group P
pregabalin +placebo
Pregabalin
One hour before spinal anesthesia, patients received pregabalin 150 mg capsule orally and the same calculated volume of normal saline till completion of the surgery
Group D
placebo + dexmedetomidine
Dexmedetomidine
One hour before spinal anesthesia, patients received placebo and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery
Group C
placebo + placebo
Placebo
One hour before spinal anesthesia, patients received placebo and the same calculated volume of normal saline till completion of the surgery
Interventions
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Pregabalin
One hour before spinal anesthesia, patients received pregabalin 150 mg capsule orally and the same calculated volume of normal saline till completion of the surgery
Dexmedetomidine
One hour before spinal anesthesia, patients received placebo and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery
Placebo
One hour before spinal anesthesia, patients received placebo and the same calculated volume of normal saline till completion of the surgery
Pregabalin and dexmedetomidine
One hour before spinal anesthesia, patients received pregabalin 150 mg orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 18-75 years
One hundred and twenty-four patients with intact cognitive function to understand this study undergoing elective total knee or hip arthroplasty under spinal anesthesia
Exclusion Criteria
* Allergic and/or contraindicated to the study drugs
* American Society of Anesthesiologists (ASA) score III and above
* Having drug
* Alcohol addiction
* Renal failure
* Diabetes mellitus
* Epilepsy
* currently using opioids for chronic pain and/or any of the drugs studied.
19 Years
75 Years
ALL
Yes
Sponsors
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Wonkwang University Hospital
OTHER
Responsible Party
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Cheol Lee
Professor,M.D.,Ph.D
Principal Investigators
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Gilho Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Wonkwang University Hospital
Locations
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WonwangUH
Iksan, Jeollabuk-do, South Korea
Countries
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Other Identifiers
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WonkwangUH5
Identifier Type: -
Identifier Source: org_study_id
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