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Dexmedetomidine for Prevention of Postoperative Delirium in Heart Surgery
NCT00464763Phase 3
Key facts
- Status
- Withdrawn
- Start
- Apr 2007
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Drugs
- dexmedetomidine
- Conditions
- postoperative delirium (POD)
01
Overview
Phase 3, randomised, double-blind trial in postoperative delirium (POD) comparing Dexmedetomidine with Placebo (2 arms). Primary endpoint: Percentage of subjects who experienced any postoperative delirium up to 3 days following surgery. Planned start Apr 2007; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dexmedetomidine
Dexmedetomidine administered intravenously starting at sternal closure.
Placebo
Placebo administered intravenously starting at sternal closure.
03
Who it enrols
Adult patients undergoing elective heart valve surgery (with or without CABG) using CPB, requiring overnight ICU stay. Excludes patients with cognitive impairment (MMSE <= 20), prior delirium, or chronic anti-psychotic use.
04
Endpoints
Primary
Percentage of subjects who experienced any postoperative delirium up to 3 days following surgery
Secondary
Daily percentage of subjects who experienced postoperative delirium
Duration of postoperative delirium as determined by CAM-ICU up to 3 days post surgery
Postoperative use of all analgesics
Time to extubation after arrival in ICU
Length of ICU stay
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