Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients (DoserespDex)

Turku University Hospital (TYKS)

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Dexmedetomidine; Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT02454881

T97/2015

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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107 participants in 4 patient groups

Placebo

Active Comparator group

Description:

Oxycodone 1 mg / ml alone

Treatment:

Drug: Oxycodone

Dexmedetomidine 2.5

Active Comparator group

Description:

Oxycodone 1 mg / mL + Dexmedetomidine 2,5 μg / mL

Treatment:

Drug: Oxycodone

Drug: Dexmedetomidine

Dexmedetomidine 5

Active Comparator group

Description:

Oxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL

Treatment:

Drug: Oxycodone

Drug: Dexmedetomidine

Dexmedetomidine 10

Active Comparator group

Description:

Oxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL

Treatment:

Drug: Oxycodone

Drug: Dexmedetomidine