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

Plain Language Summary

Simplified for easier understanding

This study looks at the best dose of dexmedetomidine (a sedation medication) for elderly ICU patients aged 65 and above who are on a breathing machine. Current dosing guidelines suggest lower doses for older patients, but the exact right dose is not yet known. The study will collect blood samples during sedation to analyze how the drug behaves in the body and recommend the safest and most effective dose for older ICU patients. You may be eligible if: - You are 65 years or older - You are in the ICU and require breathing machine support for at least 48 hours - You need sedation as part of your ICU care You may NOT be eligible if: - You or your family refuses participation - You have had a previous bad reaction to alpha-2 agonist medications - You have a second-degree or higher heart block - You have liver failure - You have kidney failure requiring dialysis Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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