Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients

Study Overview
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Brief Summary
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To study the multimodal protocol combining adjunct dexmedetomidine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation.

Official Title
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Dose Response Study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in Orthopaedic Spine Surgery Patients

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia. Written informed consent from the participating subject Exclusion Criteria: A previous history of intolerance to the study drug or related compounds and additives 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo<br>Oxycodone 1 mg / ml alone | Drug: Oxycodone<br> <br> * Other names: Oxanest;|
| Active Comparator: Dexmedetomidine 2.5<br>Oxycodone 1 mg / mL + Dexmedetomidine 2,5 μg / mL | Drug: Dexmedetomidine<br> <br> * Other names: Dexdor;Drug: Oxycodone<br> <br> * Other names: Oxanest;|
| Active Comparator: Dexmedetomidine 5<br>Oxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL | Drug: Dexmedetomidine<br> <br> * Other names: Dexdor;Drug: Oxycodone<br> <br> * Other names: Oxanest;|
| Active Comparator: Dexmedetomidine 10<br>Oxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL | Drug: Dexmedetomidine<br> <br> * Other names: Dexdor;Drug: Oxycodone<br> <br> * Other names: Oxanest;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in opioid consumption (mg) postoperatively | Change from baseline opioid consumption (mg) postoperatively at 24 hours | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in numerical rating scale (NRS 0-10) | Number of patients with numerical rating scale value under 3 | 72 hours | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Efficacy of dexmedetomidine as an adjuvant in postoperative analgesia with oxycodone after spinal surgery | 72 hours |