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Dexmedetomidine for the Treatment of Delirium After Heart Surgery

NCT01140529 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2016-11-01

No results posted yet for this study

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

DRUG

Dexmedetomidine

Bolus and continuous infusion

DRUG

Haloperidol

Bolus doses

DRUG

Saline

Bolus and continuous infusion

Sponsors & Collaborators

  • Thorax-Kärlkliniken

    lead OTHER

Principal Investigators

  • Sten M Walther, MD PhD · ThoraxKärlkliniken, University Hospital, Linköping, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01140529 on ClinicalTrials.gov