Knee OsteoarthritisPhase 4TKADEXNCT04859283
Premedication with Intranasal Dexmedetomidine in Sedation of Patients Undergoing Total Knee Arthroplasty
A Phase 4 study testing Dexmedetomidine in people with Knee Osteoarthritis and Pain, Postoperative, run by Turku University Hospital at 1 site in Finland.
Trial summary
This study aims to find out if preoperatively given dexmedetomidine is effective analgesic adjuvant for treating postoperative pain in patients undergoing elective total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Pain, Postoperative
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 10 Jun 2022to 20 Jan 2025
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is scheduled for elective unilateral total knee arthroplasty (TKA) under spinal anesthesia
- Fluent skills in finnish language (to understand the given information and to be able to give informed consent and communicate with the study personnel)
- Age between 35 and 80 years
- Weight between 50 and 100 kg
- American Society of Anesthesiologists status 1-3
- Written informed consent from the patient
Who cannot join
- A previous history of intolerance to the study drug or related compounds and additives
- Disease or condition affecting patient's ability to give written informed consent
- Existing or recent disease possible affecting absorption, distribution, metabolism, excretion or response to the study drug
- History of severe cardiac disease (valvular insufficiency, severe left ventricular dysfunction) or abnormal ECG rhythm (bradycardia < 50/min, 2nd or 3rd degree atrioventricular-block, pacemaker)
- Preoperative systolic blood pressure <110 mmHg
- Chronic use of strong opioids, pregabalin, gabapentin, amitriptyline or duloxetine
Show all 10Show fewer
- Participation in any other study concomitantly or within one month prior to the entry into this study
- Clinically significant abnormal findings in physical examination or laboratory screening
- Pregnancy or breastfeeding
- Use of any drugs known to cause enzyme induction or inhibition for a period of 30 days prior to the study, use of any natural products (including grapefruit products) for at least 14 days prior to the study and caffeine containing products for at least 24 hours prior to the study. The use of regular doses of paracetamol is allowed.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital and University of Turku
Turku
About this study
This study aims to find out if preoperatively given dexmedetomidine is effective analgesic adjuvant for treating postoperative pain in patients undergoing elective total knee arthroplasty (TKA). Another aim is to determine if premedication with intranasal dexmedetomidine could provide sufficient sedation to alleviate anxiety during TKA.
Read the detailed description
Patients undergoing total knee arthroplasty (TKA) under spinal anesthesia often request sedation to alleviate anxiety. Dexmedetomidine may be ideally suited to provide sedation during surgery as it offers sedation and analgesia without causing significant respiratory depression. Furthermore, dexmedetomidine has beneficial synergistic interactions with opioids and sedative drugs.
Altogether 80 patients scheduled for elective unilateral TKA under spinal anesthesia will be included in the prospective, randomized and controlled parallel-group study. Patients will be randomized into two groups, forty patients in each group. All patients will receive preoperatively 1000 mg of oral paracetamol as premedication. One group receives a single bolus dose of intranasal 1 ug/kg dexmedetomidine (DEX group) and the other group receives euvolemic dose (10 µL/kg) of saline (PLACEBO-group).
Spinal anesthesia will be performed using bupivacaine (5 mg/mL) using 2.0-2.5 mL dose, the amount depending on the clinical judgement of the anesthesiologist responsible for the patient. If patient needs additional analgesic after spinal anesthesia, 50 µg dose of intravenous fentanyl or 3-5 mg of intravenous midazolam may be administered intraoperatively.
Postoperative pain management in the surgical ward includes oral paracetamol 1000 mg every 8 hours, and from the first postoperative day onwards patients receive oral naproxen/esomeprazole 500/20 mg twice a day. Oral oxycodone (5-10 mg) will be used, if the pain (measured with numerical rating scale, NRS, min 0, max 100, higher scores mean worse outcome) is moderate or intense (NRS>30) after paracetamol and naproxen.
Postoperative pain (NRS) and opioid consumption (mg) will be measured and analysed together with intraoperative sedative used (mg, midazolam and/or fentanyl allowed).
- Conditions
- Knee Osteoarthritis, Pain, Postoperative
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- intranasal, dexmedetomidine, multimodal analgesia
- Medical subject headings
- Osteoarthritis, Knee, 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
Intranasal dexmedetomidine 1µg/kg will be administered 30min before the induction of anesthesia using a LMA MAD Nasal-device
PlaceboDrug
Also called Saline
Intranasal saline (10 µL/kg) will be administered 30 min before the induction of anesthesia using a LMA MAD NasalTM -device. The dose is euvolemic to 1 µg/mL dexmedetomidine.
| Study group | Role | What they receive |
|---|---|---|
| DEX-group | Active comparator | intranasal dexmedetomidine 1 µg/kg Receives: Drug: Dexmedetomidine |
| PLACEBO-group | Placebo comparator | intranasal saline 10 µL/kg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in numerical rating scale (NRS 0-100 mm, min 0, max 100, higher score means worse outcome)
Number of patients with visual rating scale value under 30 mm
Measured: 24 hours
Change in intraoperative sedatives (mg) administered
Change from baseline midazolam and fentanyl consumption (mg)
Measured: From anesthesia induction to the end of surgery.
Change in opioid consumption (mg) postoperatively
Change from baseline opioid consumption (mg) postoperatively at 24 hours
Measured: 24 hours
Secondary outcomes (3)
Change (mmHg) in hemodynamic parameter (blood pressure)
More than 30% change from the baseline in the blood pressure (measured in mmHg)
Measured: 24 hours
Change (%) in respiratory parameter (peripheral oxygen saturation, SpO2)
More than 10% change from the baseline in the SpO2 (measured %)
Measured: 24 hours
Number of patients with adverse events as a measure of safety and tolerability
Number of patients with adverse events as a measure of safety and tolerability
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start10 Jun 2022
- Primary completion15 Sep 2023
- Study completion20 Jan 2025
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 Knee OsteoarthritisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Teijo Saari, MD, PhD, Turku University Hospital
- Investigators
- Suvi-Maria Tiainen, MD, Principal investigator, Turku University Hospital, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859283
- Sponsor's protocol ID
- TKADEX
- Acronym
- TKADEX
- Status last verified
- Jan 2025
- First submitted
- 21 Apr 2021
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tiainen SM, Heinonen H, Koskinen A, Makela S, Laitio R, Loyttyniemi E, Makela K, Saari TI, Uusalo P. Premedication with intranasal dexmedetomidine in patients undergoing total knee arthroplasty under spinal anaesthesia (TKADEX)-a prospective, double-blinded, randomised controlled trial. BJA Open. 2025 Mar 3;13:100382. doi: 10.1016/j.bjao.2025.100382. eCollection 2025 Mar.
PubMed 40114985
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication with Intranasal Dexmedetomidine in Sedation of Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04859283
- Acronym / sponsor ID
- TKADEX / TKADEX
- Conditions
- Knee Osteoarthritis, Pain, Postoperative
- Keywords
- intranasal, dexmedetomidine, multimodal analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 26 Apr 2021 (actual)
- 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.
This study aims to find out if preoperatively given dexmedetomidine is effective analgesic adjuvant for treating postoperative pain in patients undergoing elective total knee arthroplasty (TKA). Another aim is to determine if premedication with intranasal dexmedetomidine could provide sufficient sedation to alleviate anxiety during TKA.
Detailed description
Patients undergoing total knee arthroplasty (TKA) under spinal anesthesia often request sedation to alleviate anxiety. Dexmedetomidine may be ideally suited to provide sedation during surgery as it offers sedation and analgesia without causing significant respiratory depression. Furthermore, dexmedetomidine has beneficial synergistic interactions with opioids and sedative drugs.
Altogether 80 patients scheduled for elective unilateral TKA under spinal anesthesia will be included in the prospective, randomized and controlled parallel-group study. Patients will be randomized into two groups, forty patients in each group. All patients will receive preoperatively 1000 mg of oral paracetamol as premedication. One group receives a single bolus dose of intranasal 1 ug/kg dexmedetomidine (DEX group) and the other group receives euvolemic dose (10 µL/kg) of saline (PLACEBO-group).
Spinal anesthesia will be performed using bupivacaine (5 mg/mL) using 2.0-2.5 mL dose, the amount depending on the clinical judgement of the anesthesiologist responsible for the patient. If patient needs additional analgesic after spinal anesthesia, 50 µg dose of intravenous fentanyl or 3-5 mg of intravenous midazolam may be administered intraoperatively.
Postoperative pain management in the surgical ward includes oral paracetamol 1000 mg every 8 hours, and from the first postoperative day onwards patients receive oral naproxen/esomeprazole 500/20 mg twice a day. Oral oxycodone (5-10 mg) will be used, if the pain (measured with numerical rating scale, NRS, min 0, max 100, higher scores mean worse outcome) is moderate or intense (NRS>30) after paracetamol and naproxen.
Postoperative pain (NRS) and opioid consumption (mg) will be measured and analysed together with intraoperative sedative used (mg, midazolam and/or fentanyl allowed).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEX-group | Active comparator | Drug: Dexmedetomidineintranasal dexmedetomidine 1 µg/kg |
| PLACEBO-group | Placebo comparator | Drug: Placebointranasal saline 10 µL/kg |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient is scheduled for elective unilateral total knee arthroplasty (TKA) under spinal anesthesia
- Fluent skills in finnish language (to understand the given information and to be able to give informed consent and communicate with the study personnel)
- Age between 35 and 80 years
- Weight between 50 and 100 kg
- American Society of Anesthesiologists status 1-3
Key exclusion criteria (10 listed)
- A previous history of intolerance to the study drug or related compounds and additives
- Disease or condition affecting patient's ability to give written informed consent
- Existing or recent disease possible affecting absorption, distribution, metabolism, excretion or response to the study drug
- History of severe cardiac disease (valvular insufficiency, severe left ventricular dysfunction) or abnormal ECG rhythm (bradycardia < 50/min, 2nd or 3rd degree atrioventricular-block, pacemaker)
- Preoperative systolic blood pressure <110 mmHg
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: DexdorIntranasal dexmedetomidine 1µg/kg will be administered 30min before the induction of anesthesia using a LMA MAD Nasal-device | Drug | DEX-group |
| PlaceboAlso: SalineIntranasal saline (10 µL/kg) will be administered 30 min before the induction of anesthesia using a LMA MAD NasalTM -device. The dose is euvolemic to 1 µg/mL dexmedetomidine. | Drug | PLACEBO-group |
Primary outcome
Change in numerical rating scale (NRS 0-100 mm, min 0, max 100, higher score means worse outcome)
Time frame: 24 hours
Number of patients with visual rating scale value under 30 mm
Change in intraoperative sedatives (mg) administered
Time frame: From anesthesia induction to the end of surgery.
Change from baseline midazolam and fentanyl consumption (mg)
Change in opioid consumption (mg) postoperatively
Time frame: 24 hours
Change from baseline opioid consumption (mg) postoperatively at 24 hours
3 secondary outcomes
Change (mmHg) in hemodynamic parameter (blood pressure)
Time frame: 24 hours
Change (%) in respiratory parameter (peripheral oxygen saturation, SpO2)
Time frame: 24 hours
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 24 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 Jan 2025.
- Derived from this study: PubMed 40114985Tiainen SM, Heinonen H, Koskinen A, Makela S, Laitio R, Loyttyniemi E, Makela K, Saari TI, Uusalo P. Premedication with intranasal dexmedetomidine in patients undergoing total knee arthroplasty under spinal anaesthesia (TKADEX)-a prospective, double-blinded, randomised controlled trial. BJA Open. 2025 Mar 3;13:100382. doi: 10.1016/j.bjao.2025.100382. eCollection 2025 Mar.
- 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.
Suvi-Maria Tiainen, MD principal investigator
Turku University Hospital, 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 in people with Knee Osteoarthritis and 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 6 inclusion and 10 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 Jan 2025. 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. Some participants in this study may receive a placebo. 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 numerical rating scale (NRS 0-100 mm, min 0, max 100, higher score means worse outcome) (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 NCT04859283, 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 Jan 2025.