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

Dose response study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in orthopaedic spine surgery patients - DoserespDex_2.0

Status

Active, not recruiting

Phases

Phase 1Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003252-31-FI

Enrollment

Registered

2015-04-22

Start date

2015-05-15

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients, who are scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation MedDRA version: 17.1 Level: LLT Classification code 10041595 Term: Spinal stenosis lumbar System Organ Class: 100000004859

Interventions

Trade Name: Dexdor Pharmaceutical Form: Infusion INN or Proposed INN: deksmedetomidiini CAS Number: 145108-58-3 Other descriptive name: DEXMEDETOMIDINE HYDROCHLORIDE Trade Name: Oxanest Pharmaceutica

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): All pain measurements have been taken;Timepoint(s) of evaluation of this end point: 72 hours after the end of surgery	—

Countries

Finland

Contacts

Public ContactTeijo Saari

University of Turku

teijo.saari@utu.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026