Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients
- Registration Number
- NCT02454881
- Lead Sponsor
- Turku University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Oxycodone Oxycodone 1 mg / ml alone Dexmedetomidine 2.5 Dexmedetomidine Oxycodone 1 mg / mL + Dexmedetomidine 2,5 μg / mL Dexmedetomidine 2.5 Oxycodone Oxycodone 1 mg / mL + Dexmedetomidine 2,5 μg / mL Dexmedetomidine 10 Dexmedetomidine Oxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL Dexmedetomidine 10 Oxycodone Oxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL Dexmedetomidine 5 Dexmedetomidine Oxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL Dexmedetomidine 5 Oxycodone Oxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL
- Primary Outcome Measures
Name Time Method Change in opioid consumption (mg) postoperatively 24 hours Change from baseline opioid consumption (mg) postoperatively at 24 hours
- Secondary Outcome Measures
Name Time Method Change in numerical rating scale (NRS 0-10) 72 hours Number of patients with numerical rating scale value under 3
Number of Participants with Adverse Events as a Measure of Safety and Tolerability 72 hours Efficacy of dexmedetomidine as an adjuvant in postoperative analgesia with oxycodone after spinal surgery
Trial Locations
- Locations (1)
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
🇫🇮Turku, Finland