NCT01140529

Dexmedetomidine for the Treatment of Delirium After Heart Surgery

A Prospective, Multi-centre, Randomised, Double-blind, Placebo-controlled Comparison of Intravenous Dexmedetomidine and Haloperidol in Treatment of Psychomotor Confusion After Heart Surgery

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Thorax-Kärlkliniken · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative
• Delirium
• Psychomotor
• Confusion

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Bolus and continuous infusion
DRUG	Haloperidol	Bolus doses
DRUG	Saline	Bolus and continuous infusion

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2010-06-09
• Last updated: 2016-11-01

Locations

1 site across 1 country: Sweden