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

Phase 4

Recruiting

• Conditions: Intensive Care patients aged 65 and more; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12612000892819
• Lead Sponsor: oorjahan Haneem binti Md Hashim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Optimal dose of dexmedetomidine in elderly patients in a Malaysian Intensive Care Unit will be assessed clinically with the RASS (Richmond Agitation Sedation Scale), mean arterial pressure and heart rate.[After completion of data collection]

Secondary Outcome Measures

Name	Time	Method
Population pharmacokinetics will be determined with serum samples taken at different intervals during dexmedetomidine infusion, and analysed via chromatography. Data collected will be analysed via NONMEM.[After completion of data collection]