ow Dose Dexmedetomidine and Delirium After Cardiac Surgery
Phase 1
- Conditions
- To find if Dexmedetomidine in cardiac surgery would have any neuroprotective effects by stimulating the alpha 2A-receptors and as such would decrease the incidence of postoperative delirium.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2017-002007-97-BE
- Lead Sponsor
- Cliniques universitaires Saint-Luc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
Inclusion Criteria
Patients undergoing cardiac surgery with cardiopulmonary bypass
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
Exclusion Criteria
• Hepaticdysfunction (hepatic function tests 3 times the normal value)
• Renal dysfunction requiring preoperative renal replacement
• Preoperative delirium
• Emergency surgery
• Patients not speaking French
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of our study is to elucidate whether the administration of<br>Dexmedetomidine at a low dose would decrease the incidence of PD in elderly patients undergoing cardiac surgery. The hypothesis is that Dexmedetomidine at low doses, by only stimulating the alpha2A adrenoceptors,would have neuroprotective affects ans as such decrease the incidence of PD.<br>Dexmedetomidine would also have anti-inflammatory effects and effects on the quality of sleep, both of which mechanisms that would play a role in the pathophysiology of PD.;Secondary Objective: Not applicable;Primary end point(s): The incidence of delirium detected by means of CAM-ICU and CAM;Timepoint(s) of evaluation of this end point: During the time of the hospitalization
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Number of days spent in delirium;Timepoint(s) of evaluation of this end point: Measure the delirious state in days