Optimising post-operative sedation for Cardiac Intensive Care in patients undergoing elective cardiac surgery involving cardiopulmonary bypass.

Phase 4

Withdrawn

• Conditions: Post-operative sedation; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12609000199213
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Any patient undergoing elective cardiac surgery involving cardipulmonary bypass 18 years or older who provides written informed consent

Exclusion Criteria

-allergic to alpha-2 adronoceptor agonists
-alltergic to propofol
-known to be pregnant or breastfeeding
-history of drug abuse
-enrolled in another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration effect relationship for dexmedetomidine and sedation, blood pressure & heart rate. Concentration of drug will be measured by Liquid Chromatrogrphy-Mass Spectrometry-Mass Spectrometry (LC-MS-MS) assay and concentration-effect relationship for Pharmacodynamic parameters will be modelled using Non Linear Mixed Effects Models.[0, 5, 10, 15, 20, 30, 45, 60 minutes, 2 and 3 hours following termination of drug infusion]

Secondary Outcome Measures

Name	Time	Method
Effect of dexmedetomidine on sleep-wake cycles and sleep disturbance in the Intensive Care Unit (ICU). Sleep will be measured using Actigarphy and Processed Electroencephalography (EEG) (Bisprectral Index (BIS)) monitoring.[Sleep will be continuously monitored for up to 2 days post-operation.]