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The Effects of Dexmedetomidine to Postoperative Awakening and Extubation-related Changes in Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01871129
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: Dexmedetomidine Other: Saline (placebo) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Postoperative Dexmedetomidine Sedation to Haemodynamics During Extubation
Actual Study Start Date : June 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 30, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Saline group
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.
Other: Saline (placebo)
Saline placebo infusion will be adjusted the same fashion as the active comparator drug.
Other Names:
  • Saline 0,9%
  • Normal saline

Active Comparator: Dexmedetomidine group
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.
Drug: Dexmedetomidine
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.
Other Name: Dexdor




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871129


Locations
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Finland
TAYS Sydänkeskus Oy (Heart Center CO. Tampere University Hospital)
Tampere, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
Investigators
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Principal Investigator: Kati M Järvelä, MD PhD TAYS Sydänkeskus Oy (Heart Center CO. Tampere University Hospital)
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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01871129    
Other Study ID Numbers: R13046M
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Keywords provided by Tampere University Hospital:
Dexmedetomidine
Postoperative Period
Airway extubation
Systolic Pressure
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action