Skip to content

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.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000892819
Enrollment
60
Registered
2012-08-22
Start date
2011-11-08
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Sponsors

Noorjahan Haneem binti Md Hashim
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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 criteria

1. Patient or relative refusal 2. Previous adverse reaction to alpha2 agonists 3. Second degree or higher heart blocks 4. Liver failure 5. Kidney failure requiring renal replacement therapy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026