Haemodynamic Effects of DexmedetomidinePhase 4NCT02566863
Haemodynamic Effect of Dexmedetomidine
A Phase 4 study testing Dexmedetomidine in people with Haemodynamic Effects of Dexmedetomidine, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Dexmedetomidine, selective alfa2 receptors agonist produces sympatholysis. As a result heart rate decreases. With low doses blood pressure also decreases, with higher dosing - systematic vascular resistance increases. The indication for the drug is to produce sedation during surgical procedures and in ICU patients. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Haemodynamic Effects of Dexmedetomidine
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2015to Aug 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients classified with American Society of Anesthesiologists Physical Status Classification System as 1 or 2 status
- planned eye surgery under sedation
Who cannot join
- patient's refusal
- contraindications to dexmedetomidine
- diseases/drugs that influence on autonomic nervous system activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Haemodynamic Effect of Dexmedetomidine in Relation to Autonomic System Activity
Dexmedetomidine, selective alfa2 receptors agonist produces sympatholysis. As a result heart rate decreases. With low doses blood pressure also decreases, with higher dosing - systematic vascular resistance increases. The indication for the drug is to produce sedation during surgical procedures and in ICU patients.
The aim of a study is to verify, whether the haemodynamic effect (heart rate, blood pressure and heart rate variability during drug infusion) depend on pre-drug autonomic system activity. Autonomic system activity is assessed using heart rate variability (HRV)measurement before drug injection and during drug infusion. Heart rate and blood pressure measured before and during drug infusion will be analysed.
HRV measurement analysis will be based on continuous Holter ECG recording, taken before drug injection and during its infusion. 5 minutes intervals will be analysed , using Frequency Domain Measures of HRV. Surgical procedure will start after measurement have been taken.
- Conditions
- Haemodynamic Effects of Dexmedetomidine
- Being tested
- Dexmedetomidine
- Keywords
- dexmedetomidine, heart rate, heart rate variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexdor, Precedex
1 mcg/kg over 10 minutes, followed by a maintenance infusion titrated to achieve desired clinical effect - Richmond Agitation Scale between 0 and (-) 3. Holter ECG recording before start of infusion and during infusion for 25 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine, 1 mcg/kg over 10 minutes, followed by a maintenance infusion, given to achieve sedation for eye surgery procedure Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of haemodynamics and heart rate variability parameters
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemodynamic Effects of DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Wujtewicz, Medical University of Gdansk
- Investigators
- Magdalena A Wujtewicz, M.D, Principal investigator, Department of Ophthalmology, Medical University of Gdańsk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566863
- Sponsor's protocol ID
- GUMed-Wu-003
- Status last verified
- Oct 2021
- First submitted
- 30 Sep 2015
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamic Effect of Dexmedetomidine in Relation to Autonomic System Activity
- ClinicalTrials.gov ID
- NCT02566863
- Acronym / sponsor ID
- GUMed-Wu-003
- Conditions
- Haemodynamic Effects of Dexmedetomidine
- Keywords
- dexmedetomidine, heart rate, heart rate variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 2 Oct 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.
Dexmedetomidine, selective alfa2 receptors agonist produces sympatholysis. As a result heart rate decreases. With low doses blood pressure also decreases, with higher dosing - systematic vascular resistance increases. The indication for the drug is to produce sedation during surgical procedures and in ICU patients.
The aim of a study is to verify, whether the haemodynamic effect (heart rate, blood pressure and heart rate variability during drug infusion) depend on pre-drug autonomic system activity. Autonomic system activity is assessed using heart rate variability (HRV)measurement before drug injection and during drug infusion. Heart rate and blood pressure measured before and during drug infusion will be analysed.
HRV measurement analysis will be based on continuous Holter ECG recording, taken before drug injection and during its infusion. 5 minutes intervals will be analysed , using Frequency Domain Measures of HRV. Surgical procedure will start after measurement have been taken.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineDexmedetomidine, 1 mcg/kg over 10 minutes, followed by a maintenance infusion, given to achieve sedation for eye surgery procedure |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients classified with American Society of Anesthesiologists Physical Status Classification System as 1 or 2 status
- planned eye surgery under sedation
Key exclusion criteria (3 listed)
- patient's refusal
- contraindications to dexmedetomidine
- diseases/drugs that influence on autonomic nervous system activity
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, Precedex1 mcg/kg over 10 minutes, followed by a maintenance infusion titrated to achieve desired clinical effect - Richmond Agitation Scale between 0 and (-) 3. Holter ECG recording before start of infusion and during infusion for 25 minutes. | Drug | Dexmedetomidine |
Primary outcome
Changes of haemodynamics and heart rate variability parameters
Time frame: up to 30 minutes
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 18 Oct 2021.
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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.
Magdalena A Wujtewicz, M.D principal investigator
Department of Ophthalmology, Medical University of Gdańsk
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 Haemodynamic Effects of Dexmedetomidine, run by Medical University of Gdansk at 1 site in Poland.
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 3 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 18 Oct 2021. 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 Poland. 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?
Changes of haemodynamics and heart rate variability parameters (time frame: up to 30 minutes). 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 18 Oct 2021.