Hypertension Clinical Trial
Official title:
The Effects of Postoperative Dexmedetomidine Sedation to Haemodynamics During Extubation
Verified date | May 2017 |
Source | Tampere University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 30, 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Finland | TAYS Sydänkeskus Oy (Heart Center CO. Tampere University Hospital) | Tampere |
Lead Sponsor | Collaborator |
---|---|
Tampere University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Starting five minutes before the extubation, lasting up to 1.5 hours. | |
Secondary | 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. | Starting at the point when propofol infusion is halted and lasting up to three hours after extubation. |
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