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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01140529

Acronym

DexinDelir

Enrollment

Registered

2010-06-09

Start date

2010-05-31

Completion date

2012-06-30

Last updated

2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Confusion, Delirium, Postoperative, Psychomotor

Keywords

Dexmedetomidine

Brief 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.

Interventions

DRUGDexmedetomidine

Bolus and continuous infusion

DRUGHaloperidol

Bolus doses

DRUGSaline

Bolus and continuous infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \> 65 years * Clinical need for treatment of psychomotor confusion unresponsive to standard analgesic medication (RASS +2 to +3) * Heart surgery and extracorporeal circulation (ECC) within 7 days * Written informed consent obtained before surgery * Mentally competent at the time of written informed consent

Exclusion criteria

* Ongoing neuroleptic, propofol and α2 agonist medication * Intubated patient * Uncompensated acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure \< 55 mmHg despite volume, vasopressors and IABP) * Severe bradycardia without pacemaker backup (heart rate \< 50 beats/min) * AV-conduction block II-III (without pacemaker backup) * Severe hepatic impairment (Serum bilirubin \> 101 µmol/l) * Lithium therapy

Design outcomes

Primary

Measure	Time frame
Need for rescue medication	72 hours

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026