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

The effect of Dexmedetomidine versus Propofol in optimising post-operative sedation in patients undergoing elective cardiac surgery involving cardiopulmonary bypass.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000199213

Acronym

OSCI

Enrollment

Registered

2009-04-21

Start date

2009-05-01

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

The primary purpose of this study is to investigate the concentration effect relationship for dexmedetomidine and sedation, heart rate and blood pressure in adult patients undergoing elective cardiac surgery involving cardiopulmonary bypass as this is previously unreported. We also want to examine the effect of dexmedetomidine on postoperative sleep wake cycles compared to propofol.

Interventions

Dexmedetomidine - Intravenous dexmedetomidine as a continuous infusion of 0.2-2.5 mcg/kg/h titrated to effect (level of sedation) from end of surgery until weaning for extubation from mechanical ventilation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results