PharmacokineticsPhase 4INDEXNCT05065775
Bioavailability of Intranasal Dexmedetomidine
A Phase 4 study testing Dexmedetomidine in people with Pharmacokinetics and Arthritis Knee, run by Turku University Hospital at 1 site in Finland.
Trial summary
Aim of this study is to characterize the pharmacokinetics of dexmedetomidine in supine, anesthetized adult patients after intranasal dosing. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Pharmacokinetics, Arthritis Knee, Arthritis of Hip
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 1 Nov 2021to 10 May 2022
- 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 85 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 or hip arthroplasty under general 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
- ASA (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 significant disease possible affecting absorption, distribution, metabolism, excretion or response to the study drug
- History of cardiac disease (valvular insufficiency, severe left ventricular dysfunction) or abnormal ECG rhythm (bradycardia < 50/min, 2nd or 3rd degree atrio-ventricular block, pacemaker)
- Chronic opioid use or use of other analgesic adjuvants such as pregabalin, gabapentin, amitriptyline or duloxetine
- Participation in any other study concomitantly or within one month prior to the entry into this study
Show all 11Show fewer
- Clinically significant abnormal findings in physical examination or laboratory screening
- Use of drugs or natural products known to cause enzyme induction or inhibition
- Pregnancy or breastfeeding
- Spinal anesthesia
- Preoperative systolic blood pressure <110 mmHg
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
Official title: Intranasal Dexmedetomidine Pharmacokinetics on Patients Under General Anesthesia
Aim of this study is to characterize the pharmacokinetics of dexmedetomidine in supine, anesthetized adult patients after intranasal dosing.
Read the detailed description
To date, intranasal dexmedetomidine pharmacokinetics have not been studied before on anesthetized adult patients in supine position. As use of intranasal dexmedetomidine is growing, it is crucial to enhance knowledge of its pharmacokinetics.
Open, exploratory study design will be used. Study population will consist of patients coming to elective unilateral hip or knee arthroplasty under general anesthesia in Turku University Hospital, Salo unit. Thirty patients compatible with the inclusion and exclusion criteria will be entered into the study after receiving informed consent. Plasma concentrations of dexmedetomidine and other significant data will be collected prospectively.
Intranasal dexmedetomidine 100 ug will be administered shortly after induction of general anesthesia using a mucosal atomization (LMA MAD Nasal™) device, according to normal local protocol. Second cannula will be placed after patient is anesthetized, in order to obtain blood samples. Venous blood samples will be obtained immediately prior to administration of dexmedetomidine (baseline) and thereafter at 5, 15, 45 min and 1, 4 h into EDTA tubes for determination of dexmedetomidine, and possibly adrenaline and noradrenaline plasma concentrations.
Vital signs (heart rate, blood pressure and peripheral oxygen saturation) will be followed during the operation, as well as in the post anesthesia care unit according to the local protocol. Before patients will be admitted to the ward, they are expected to be appropriately arousable and have vital signs in normal limits.
- Conditions
- Pharmacokinetics, Arthritis Knee, Arthritis of Hip, Anesthesia
- Being tested
- Dexmedetomidine
- Keywords
- Intranasal, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDevice
Also called Dexdor
Single intranasal dexmedetomidine dose of 100 µg. Intranasal dexmedetomidine will be administered shortly after induction of anesthesia using a mucosal atomization devise (LMA MAD Nasal™)
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Single intranasal 100 µg bolus dose of dexmedetomidine Receives: Device: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability (%) of intranasally given dexmedetomidine
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2021
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Panu Uusalo, MD, PhD, Principal investigator, University of Turku and Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065775
- Sponsor's protocol ID
- INDEX
- Acronym
- INDEX
- Status last verified
- May 2022
- First submitted
- 1 Oct 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine Pharmacokinetics on Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05065775
- Acronym / sponsor ID
- INDEX / INDEX
- Conditions
- Pharmacokinetics, Arthritis Knee, Arthritis of Hip, Anesthesia
- Keywords
- Intranasal, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 4 Oct 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.
Aim of this study is to characterize the pharmacokinetics of dexmedetomidine in supine, anesthetized adult patients after intranasal dosing.
Detailed description
To date, intranasal dexmedetomidine pharmacokinetics have not been studied before on anesthetized adult patients in supine position. As use of intranasal dexmedetomidine is growing, it is crucial to enhance knowledge of its pharmacokinetics.
Open, exploratory study design will be used. Study population will consist of patients coming to elective unilateral hip or knee arthroplasty under general anesthesia in Turku University Hospital, Salo unit. Thirty patients compatible with the inclusion and exclusion criteria will be entered into the study after receiving informed consent. Plasma concentrations of dexmedetomidine and other significant data will be collected prospectively.
Intranasal dexmedetomidine 100 ug will be administered shortly after induction of general anesthesia using a mucosal atomization (LMA MAD Nasal™) device, according to normal local protocol. Second cannula will be placed after patient is anesthetized, in order to obtain blood samples. Venous blood samples will be obtained immediately prior to administration of dexmedetomidine (baseline) and thereafter at 5, 15, 45 min and 1, 4 h into EDTA tubes for determination of dexmedetomidine, and possibly adrenaline and noradrenaline plasma concentrations.
Vital signs (heart rate, blood pressure and peripheral oxygen saturation) will be followed during the operation, as well as in the post anesthesia care unit according to the local protocol. Before patients will be admitted to the ward, they are expected to be appropriately arousable and have vital signs in normal limits.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Device: DexmedetomidineSingle intranasal 100 µg bolus dose of dexmedetomidine |
Who may qualify
- Ages
- 35 to 85 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 or hip arthroplasty under general 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
- ASA (American Society of Anesthesiologists) status 1-3
Key exclusion criteria (11 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 significant disease possible affecting absorption, distribution, metabolism, excretion or response to the study drug
- History of cardiac disease (valvular insufficiency, severe left ventricular dysfunction) or abnormal ECG rhythm (bradycardia < 50/min, 2nd or 3rd degree atrio-ventricular block, pacemaker)
- Chronic opioid use or use of other analgesic adjuvants such as pregabalin, gabapentin, amitriptyline or duloxetine
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: DexdorSingle intranasal dexmedetomidine dose of 100 µg. Intranasal dexmedetomidine will be administered shortly after induction of anesthesia using a mucosal atomization devise (LMA MAD Nasal™) | Device | Dexmedetomidine |
Primary outcome
Relative bioavailability (%) of intranasally given dexmedetomidine
Time frame: 4 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 17 May 2022.
- 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.
Panu Uusalo, MD, PhD principal investigator
University of Turku and Turku University Hospital
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 Pharmacokinetics and Arthritis Knee, 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 11 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 17 May 2022. 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?
Relative bioavailability (%) of intranasally given dexmedetomidine (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2022.