HypertensionPhase 4NCT01871129
The Effects of Dexmedetomidine to Postoperative Awakening and Extubation-related Changes in Blood Pressure
A Phase 4 study testing Dexmedetomidine in people with Hypertension, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The postoperative removal of intubation tube induces a noticeable sympathic response and increase of blood pressure. The risk of complications is especially elevated with the patients having cardiac surgery. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2013to 30 Apr 2014
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has to be scheduled for aortic valve surgery OR previous AND coronary artery bypass
- Patient has to be 60 to 90 years of age
Who cannot join
- If a patient is unable to give informed concent to participate the study
- If a patient is allergic or otherwise hypersensitive to the drug used in the study
- If the patient has either insufficient kidney or insufficient liver function
Trial locations and contacts
1 site in 1 country.
Finland1 site
TAYS Sydänkeskus Oy (Heart Center CO. Tampere University Hospital)
Tampere, 33521
About this study
Official title: The Effects of Postoperative Dexmedetomidine Sedation to Haemodynamics During Extubation
The postoperative removal of intubation tube induces a noticeable sympathic response and increase of blood pressure. The risk of complications is especially elevated with the patients having cardiac surgery. Though sedation inhibits the sympathetic responses to extubation, according to the current protocol the propofol infusion has to be discontinued well before extubation because of its inhibitory effects on breathing centers.
Dexmedetomidine is relatively new anesthesia drug. Dexmedetomidine is unique in its characteristic that it does not have the paralyzing effect on breathing. The aim of our study is to work out whether dexmedetomidine-extended propofol sedation over the extubation diminishes the aforementioned harmful effects of the extubation procedure.
Read more
Study design is prospective double-blinded randomized study. The investigators compare two groups of 25 patients (total 50), who are of 60-90 years of age and are having either aortic valve surgery or the mentioned accompanied with cardiopulmonary bypass operation. The first group receives dexmedetomidine infusion and the other receives placebo infusion after the end of propofol infusion.
The specific goal of the study is to figure what haemodynamic - mostly blood pressure related - changes can be observed when the postoperatively cut propofol infusion is continued with dexmedetomidine over the extubation procedure.
Our hypothesis is that by using dexmedetomidine supplemented sedation the normally notifiable peak in blood pressure may be avoided.
The study will be carried out completely in Cardiac ICU in Tampere University Hospital.
- Conditions
- Hypertension
- Being tested
- Dexmedetomidine, Saline (placebo)
- Keywords
- Dexmedetomidine, Postoperative Period, Airway extubation, Systolic Pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexdor
Dexmedetomidine will be diluted into a saline solution to a recommended concentration of 4 micrograms per millilitre. The saline will then be initially administered at the rate of 0.5 micrograms/kg/h and from that point the amount will be reduced to the point where the patient breathes well and is calm (compare dexmedetomidine recommendation at 0.2-1.4 ug/kg/h). The infusion rate will then be approximately 1-10 ml/h for a patient of 80 kgs weight. The exact dosage cannot be predetermined because it differs in each individual. In the control group the infusion speed is matching.
Saline (placebo)Other
Also called Saline 0,9%, Normal saline
Saline placebo infusion will be adjusted the same fashion as the active comparator drug.
| Study group | Role | What they receive |
|---|---|---|
| Saline group | Placebo comparator | Difference from the normal protocol actualizes at the point when propofol infusion is cut off. From there on the patient in this group receives saline infusion up to the point where 15 minutes have passed after the extubation procedure. Receives: Other: Saline (placebo) |
| Dexmedetomidine group | Active comparator | Difference from the normal protocol happens when normally the propofol infusion is cut off. From there on the patient in this group receives dexmedetomidine infusion up to the point where 15 minutes have passed after the extubation procedure. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highest value of systolic blood pressure during extubation period
The values of this variable will be collected from the point when propofol infusion is cut. This data will be used to estimate the base level of SAP for further analysis within this study.
Measured: Starting five minutes before the extubation, lasting up to 1.5 hours.
Secondary outcomes (1)
Risk index calculated from systolic blood pressure value and time spent in that value.
With the risk index we are better able to assess the total risk of the high levels of blood pressure to the patient. The risk index is dependant on the time integral of the blood pressure, for which the zero-value may be calculated from average pre-extubation SAP level.
Measured: Starting at the point when propofol infusion is halted and lasting up to three hours after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completion30 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Tampere 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kati M Järvelä, MD PhD, Principal investigator, TAYS Sydänkeskus Oy (Heart Center CO. Tampere University Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871129
- Sponsor's protocol ID
- R13046M
- Status last verified
- May 2017
- First submitted
- 3 Jun 2013
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Postoperative Dexmedetomidine Sedation to Haemodynamics During Extubation
- ClinicalTrials.gov ID
- NCT01871129
- Acronym / sponsor ID
- R13046M
- Conditions
- Hypertension
- Keywords
- Dexmedetomidine, Postoperative Period, Airway extubation, Systolic Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- 30 Apr 2014 (actual)
- First posted
- 6 Jun 2013 (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.
The postoperative removal of intubation tube induces a noticeable sympathic response and increase of blood pressure. The risk of complications is especially elevated with the patients having cardiac surgery. Though sedation inhibits the sympathetic responses to extubation, according to the current protocol the propofol infusion has to be discontinued well before extubation because of its inhibitory effects on breathing centers.
Dexmedetomidine is relatively new anesthesia drug. Dexmedetomidine is unique in its characteristic that it does not have the paralyzing effect on breathing. The aim of our study is to work out whether dexmedetomidine-extended propofol sedation over the extubation diminishes the aforementioned harmful effects of the extubation procedure.
Study design is prospective double-blinded randomized study. The investigators compare two groups of 25 patients (total 50), who are of 60-90 years of age and are having either aortic valve surgery or the mentioned accompanied with cardiopulmonary bypass operation. The first group receives dexmedetomidine infusion and the other receives placebo infusion after the end of propofol infusion.
The specific goal of the study is to figure what haemodynamic - mostly blood pressure related - changes can be observed when the postoperatively cut propofol infusion is continued with dexmedetomidine over the extubation procedure.
Our hypothesis is that by using dexmedetomidine supplemented sedation the normally notifiable peak in blood pressure may be avoided.
The study will be carried out completely in Cardiac ICU in Tampere University Hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline group | Placebo comparator | Other: Saline (placebo)Difference from the normal protocol actualizes at the point when propofol infusion is cut off. From there on the patient in this group receives saline infusion up to the point where 15 minutes have passed after the extubation procedure. |
| Dexmedetomidine group | Active comparator | Drug: DexmedetomidineDifference from the normal protocol happens when normally the propofol infusion is cut off. From there on the patient in this group receives dexmedetomidine infusion up to the point where 15 minutes have passed after the extubation procedure. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has to be scheduled for aortic valve surgery OR previous AND coronary artery bypass
- Patient has to be 60 to 90 years of age
Key exclusion criteria (3 listed)
- If a patient is unable to give informed concent to participate the study
- If a patient is allergic or otherwise hypersensitive to the drug used in the study
- If the patient has either insufficient kidney or insufficient liver function
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: DexdorDexmedetomidine will be diluted into a saline solution to a recommended concentration of 4 micrograms per millilitre. The saline will then be initially administered at the rate of 0.5 micrograms/kg/h and from that point the amount will be reduced to the point where the patient breathes well and is calm (compare dexmedetomidine recommendation at 0.2-1.4 ug/kg/h). The infusion rate will then be approximately 1-10 ml/h for a patient of 80 kgs weight. The exact dosage cannot be predetermined because it differs in each individual. In the control group the infusion speed is matching. | Drug | Dexmedetomidine group |
| Saline (placebo)Also: Saline 0,9%, Normal salineSaline placebo infusion will be adjusted the same fashion as the active comparator drug. | Other | Saline group |
Primary outcome
Highest value of systolic blood pressure during extubation period
Time frame: Starting five minutes before the extubation, lasting up to 1.5 hours.
The values of this variable will be collected from the point when propofol infusion is cut. This data will be used to estimate the base level of SAP for further analysis within this study.
1 secondary outcome
Risk index calculated from systolic blood pressure value and time spent in that value.
Time frame: Starting at the point when propofol infusion is halted and lasting up to three hours after extubation.
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 5 May 2017.
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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.
Kati M Järvelä, MD PhD principal investigator
TAYS Sydänkeskus Oy (Heart Center CO. Tampere 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 Hypertension, run by Tampere 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 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 5 May 2017. 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?
Highest value of systolic blood pressure during extubation period (time frame: Starting five minutes before the extubation, lasting up to 1.5 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 5 May 2017.