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Dexmedetomidine for the Treatment of Delirium After Heart Surgery

Information source: Thorax-Kšrlkliniken
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative; Delirium; Psychomotor; Confusion

Intervention: Dexmedetomidine (Drug); Haloperidol (Drug); Saline (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Thorax-Kšrlkliniken

Official(s) and/or principal investigator(s):
Sten M Walther, MD PhD, Principal Investigator, Affiliation: ThoraxKärlkliniken, University Hospital, Linköping, Sweden

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Need for rescue medication

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 őĪ2 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 ¬Ķmol/l)

- Lithium therapy

Locations and Contacts

ThoraxKärlkliniken, Linköping SE-61293, Sweden
Additional Information

Starting date: May 2010
Last updated: January 25, 2012

Page last updated: August 23, 2015

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