Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients

Turku University Hospital107 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

107

Conditions

Pain, Postoperative

Interventions

DexmedetomidineDRUG

OxycodoneDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

Change in opioid consumption (mg) postoperatively

Change from baseline opioid consumption (mg) postoperatively at 24 hours

Time frame: 24 hours

Secondary Outcomes

Change in numerical rating scale (NRS 0-10)

Number of patients with numerical rating scale value under 3

Time frame: 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

Time frame: 72 hours

Data from ClinicalTrials.gov

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