Dexmedetomidine for the Treatment of Delirium After Heart Surgery

Phase 3

Terminated

• Conditions: Delirium; Postoperative; Psychomotor; Confusion
• Interventions: Drug: Saline; Drug: Dexmedetomidine; Drug: Haloperidol

• Registration Number: NCT01140529
• Lead Sponsor: Thorax-Kärlkliniken

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-29
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	-
Dexmedetomidine	Dexmedetomidine	-
Haloperidol	Haloperidol	-

Primary Outcome Measures

Name	Time	Method
Need for rescue medication	72 hours

Trial Locations

Locations (1)

ThoraxKärlkliniken, Universitetssjukhuset; 🇸🇪 Linköping, Sweden