drugset / Trial / NCT01140529

Dexmedetomidine for the Treatment of Delirium After Heart Surgery

NCT01140529

Phase 3 Terminated 3 enrolled Thorax-Kärlkliniken
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary hypothesis: Dexmedetomidine is equal or superior to haloperidol and placebo in the treatment of psychomotor confusion in patients who are recovering from heart surgery. Study design: Multi-centre, prospective, randomised, placebo-controlled double-blind study of dexmedetomidine vs. haloperidol for treatment of psychomotor confusion after cardiac surgery. Data will be analyzed in two steps: The primary comparison is between placebo and dexmedetomidine. If the effect of dexmedetomidine is significant, a secondary comparison between dexmedetomidine and haloperidol will follow.

Timeline

Start
2010-05
Primary completion
2012-05
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified Intravenous
Comparator Haloperidol Other / unclassified Intravenous

Indications