Dexmedetomidine for the Treatment of Delirium After Heart Surgery

NCT01140529 | Terminated Phase 3

• 1 other identifier: 3005099
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative; Delirium; Psychomotor; Confusion

Keywords

Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Need for rescue medication

  72 hours

Study Arms (3)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Haloperidol

ACTIVE COMPARATOR

Drug: Haloperidol

Placebo

PLACEBO COMPARATOR

Drug: Saline

Interventions

Dexmedetomidine DRUG

Bolus and continuous infusion

Also known as: Precedex

Dexmedetomidine

Haloperidol DRUG

Bolus doses

Also known as: Haldol

Haloperidol

Saline DRUG

Bolus and continuous infusion

Also known as: Vehicle

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thorax-Kärlkliniken: lead

Study Sites (1)

ThoraxKärlkliniken, Universitetssjukhuset

Linköping, SE-58185, Sweden

Location

MeSH Terms

Conditions

Delirium; Confusion

Interventions

Dexmedetomidine; Haloperidol; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Butyrophenones; Ketones; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sten M Walther, MD PhD

  ThoraxKärlkliniken, University Hospital, Linköping, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 9, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

SE (1)