Pain, PostoperativePhase 4DoserespDexNCT02454881
Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients
A Phase 4 study testing Dexmedetomidine and Oxycodone in people with Pain, Postoperative, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Dexmedetomidine and Oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2015to 1 Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
- Written informed consent from the participating subject
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Finland1 site
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
Turku, 20521
About this study
Official title: Dose Response Study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in Orthopaedic Spine Surgery Patients
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.
- Conditions
- Pain, Postoperative
- Being tested
- Dexmedetomidine, Oxycodone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexdor
OxycodoneDrug
Also called Oxanest
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Active comparator | Oxycodone 1 mg / ml alone Receives: Drug: Oxycodone |
| Dexmedetomidine 2.5 | Active comparator | Oxycodone 1 mg / mL + Dexmedetomidine 2,5 μg / mL Receives: Drug: Dexmedetomidine; Drug: Oxycodone |
| Dexmedetomidine 5 | Active comparator | Oxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL Receives: Drug: Dexmedetomidine; Drug: Oxycodone |
| Dexmedetomidine 10 | Active comparator | Oxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL Receives: Drug: Dexmedetomidine; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in opioid consumption (mg) postoperatively
Change from baseline opioid consumption (mg) postoperatively at 24 hours
Measured: 24 hours
Secondary outcomes (2)
Change in numerical rating scale (NRS 0-10)
Number of patients with numerical rating scale value under 3
Measured: 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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJun 2015
- Primary completion31 Oct 2019
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Teijo I Saari, MD, PhD, Principal investigator, Dept. Anaesthesiology and Intensive Care, University Of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454881
- Sponsor's protocol ID
- T97/2015
- Acronym
- DoserespDex
- Status last verified
- Sep 2020
- First submitted
- 20 May 2015
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Makela S, Saari TI, Loyttyniemi E, Aantaa R, Liukas A, Uusalo P. Haemodynamic and Respiratory Effects of Dexmedetomidine as an Adjuvant to Oxycodone Patient-Controlled Analgesia After Lumbar Spinal Fusion: A Post Hoc Analysis of the DoseRespDex Randomised Controlled Trial. Acta Anaesthesiol Scand. 2027 Jan;71(1):e70362. doi: 10.1111/aas.70362.
PubMed 42929478
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in Orthopaedic Spine Surgery Patients
- ClinicalTrials.gov ID
- NCT02454881
- Acronym / sponsor ID
- DoserespDex / T97/2015
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Helsinki
- Study start
- Jun 2015 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Active comparator | Drug: OxycodoneOxycodone 1 mg / ml alone |
| Dexmedetomidine 2.5 | Active comparator | Drug: Dexmedetomidine, Drug: OxycodoneOxycodone 1 mg / mL + Dexmedetomidine 2,5 μg / mL |
| Dexmedetomidine 5 | Active comparator | Drug: Dexmedetomidine, Drug: OxycodoneOxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL |
| Dexmedetomidine 10 | Active comparator | Drug: Dexmedetomidine, Drug: OxycodoneOxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
- Written informed consent from the participating subject
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Dexdor | Drug | Dexmedetomidine 10, Dexmedetomidine 2.5, Dexmedetomidine 5 |
| OxycodoneAlso: Oxanest | Drug | Dexmedetomidine 10, Dexmedetomidine 2.5, Dexmedetomidine 5, Placebo |
Primary outcome
Change in opioid consumption (mg) postoperatively
Time frame: 24 hours
Change from baseline opioid consumption (mg) postoperatively at 24 hours
2 secondary outcomes
Change in numerical rating scale (NRS 0-10)
Time frame: 72 hours
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Derived from this study: PubMed 42929478Makela S, Saari TI, Loyttyniemi E, Aantaa R, Liukas A, Uusalo P. Haemodynamic and Respiratory Effects of Dexmedetomidine as an Adjuvant to Oxycodone Patient-Controlled Analgesia After Lumbar Spinal Fusion: A Post Hoc Analysis of the DoseRespDex Randomised Controlled Trial. Acta Anaesthesiol Scand. 2027 Jan;71(1):e70362. doi: 10.1111/aas.70362.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teijo I Saari, MD, PhD principal investigator
Dept. Anaesthesiology and Intensive Care, University Of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Oxycodone in people with Pain, Postoperative, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in opioid consumption (mg) postoperatively (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02454881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.