Dexmedetomidine for the Treatment of Delirium After Heart Surgery

Delirium Clinical Trial

— DexinDelir  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01140529
• Other study ID #: 3005099
• Status: Terminated
• Phase: Phase 3
• First received: June 7, 2010
• Last updated: October 29, 2016
• Start date: May 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2016
• Source: Thorax-Kärlkliniken
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Läkemedelsverket
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 a2 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

Study Design

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

Related Conditions & MeSH terms

• Confusion
• Delirium
• Postoperative
• Psychomotor

Intervention

Drug:
• Dexmedetomidine
Bolus and continuous infusion
• Haloperidol
Bolus doses
• Saline
Bolus and continuous infusion

Locations

Country	Name	City	State
Sweden	ThoraxKärlkliniken, Universitetssjukhuset	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Thorax-Kärlkliniken

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for rescue medication		72 hours	No