RecruitingPhase 4ACTRN12612000892819

Dexmedetomidine pharmacodynamics and population pharmacokinetics in elderly intensive care unit (ICU) patients

Dexmedetomidine pharmacodynamics and population pharmacokinetics in elderly Intensive Care Unit (ICU) patients aged 65 and above.


Sponsor

Noorjahan Haneem binti Md Hashim

Enrollment

60 participants

Start Date

Nov 8, 2011

Study Type

Interventional

Conditions

Summary

Dexmedetomidine is a sedation medication used daily in our ICU. Though the manufacturer and literature recommends a lower dose for patient above 65 years old, the dose is yet not known. We aim to find out the best dose to be used in patients 65 years and above in our ICU, and to recommend the dose for similar patients in the whole country.


Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Inclusion Criteria1

  • Intensive Care Unit (ICU) patients at the University of Malaya Medical Centre (UMMC) requiring invasive ventilation and sedation of at least 48 hours duration

Exclusion Criteria5

  • Patient or relative refusal
  • Previous adverse reaction to alpha2 agonists
  • Second degree or higher heart blocks
  • Liver failure
  • Kidney failure requiring renal replacement therapy

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Interventions

Eligible patients will be administered 0.2 to 0.5 mcg/kg/hr intravenous dexmedetomidine to achieve RASS score of 0 to -2. Pharmacodynamic parameters monitored are the RASS score, heart rate, blood pr

Eligible patients will be administered 0.2 to 0.5 mcg/kg/hr intravenous dexmedetomidine to achieve RASS score of 0 to -2. Pharmacodynamic parameters monitored are the RASS score, heart rate, blood pressure, respiratory rate, temperature. Sparse blood samples will be taken to measure serum dexmedetomidine levels, where the population pharmacokinetics will be studied. The pharmacodynamic parameters will be continuous for 48 hours, and the blood sampling will occur six times over 48 hours.


Locations(1)

Kuala Lumpur, Malaysia

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ACTRN12612000892819