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NCT Number: NCT01871129

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

TAYS Sydänkeskus Oy (Heart Center CO. Tampere University Hospital)

Tampere, 33521, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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 names: Dexdor

Saline (Placebo)

Other

Saline placebo infusion will be adjusted the same fashion as the active comparator drug.

Other names: Saline 0,9%, Normal saline

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

The Effects of Postoperative Dexmedetomidine Sedation to Haemodynamics During Extubation

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2013
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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