Dose-response of dexmedetomidine in patient controlled analgesia in orthopaedic surgery patients

Conditions: Patients, who are scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation
MedDRA version: 17.1Level: LLTClassification code 10041595Term: Spinal stenosis lumbarSystem Organ Class: 100000004859
Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Registration Number: EUCTR2014-003252-31-FI

Lead Sponsor: niversity of Turku

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.20 - 75 years of age
2.Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
3.Written informed consent from the participating subject

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1.A previous history of intolerance to the study drug or related compounds and additives
2.Concomitant drug therapy with oxycodone or buprenorphine.
3.History of ischemic heart disease or conduction disturbance
4.BMI > 35
5.Existing significant haematological, endocrine, metabolic or gastrointestinal disease
6.History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
7.Allergy to dexmedetomidine or oxycodone
8.Blood loss exceeding 1500 ml during operation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This randomised, double-blinded, controlled study is aimed to study the dose-response using multimodal protocol combining adjunct dexmedetomidine with oxycodone in intravenous patient-controlled analgesia (PCA) bolus dosing in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation.;Secondary Objective: Building a pharmacokinetic-pharmacodynamic model for dexmedetomidine and oxycodone.;Primary end point(s): All planned blood samples have been drawn.;Timepoint(s) of evaluation of this end point: 72 h after the end of surgery.

Secondary Outcome Measures