Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients
NCT ID: NCT02454881
Last Updated: 2020-09-22
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
107 participants
INTERVENTIONAL
2015-06-30
2020-03-01
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
TRIPLE
Study Groups
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Placebo
Oxycodone 1 mg / ml alone
Oxycodone
Dexmedetomidine 2.5
Oxycodone 1 mg / mL + Dexmedetomidine 2,5 μg / mL
Dexmedetomidine
Oxycodone
Dexmedetomidine 5
Oxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL
Dexmedetomidine
Oxycodone
Dexmedetomidine 10
Oxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL
Dexmedetomidine
Oxycodone
Interventions
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Dexmedetomidine
Oxycodone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent from the participating subject
Exclusion Criteria
* Concomitant drug therapy with oxycodone or buprenorphine.
* History of ischemic heart disease or conduction disturbance
* BMI \> 35
* Existing significant haematological, endocrine, metabolic or gastrointestinal disease
* History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
* Allergy to dexmedetomidine or oxycodone
* Blood loss exceeding 1500 ml during operation
20 Years
75 Years
ALL
No
Sponsors
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University of Helsinki
OTHER
Turku University Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Teijo I Saari, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept. Anaesthesiology and Intensive Care, University Of Turku
Locations
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Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
Turku, , Finland
Countries
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Other Identifiers
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T97/2015
Identifier Type: -
Identifier Source: org_study_id
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