CompletedPhase 4ketamine

Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial

NCT ID

NCT02433041

Target Enrollment

200 participants

Start Date

2013-07

Est. Completion

2018-12-21

About This Study

The purpose of this study is to find out whether postoperative delirium can be more properly prevented by the combination of determined preventive agents in past studies. Further on the investigators measure pre- and postoperative cortisol, neuron specific enolase (NSE) and S-100beta levels.

Conditions Studied

Postoperative Delirium

Interventions

•Haloperidol
•Ketamine
•Haloperidol + Ketamine
•Saline solution (NaCl 0.9%)

Eligibility

Age:65 Years - N/A

Healthy Volunteers:Yes

View full eligibility criteria

Inclusion Criteria:

* Age 65 years and older
* Signed agreement

Exclusion Criteria:

* Delirium at admittance or MMSE score \<24 points
* High risk for postoperative ICU treatment
* Haloperidol or Ketamine intolerance
* Risk of lack of cooperation
* Drug an alcohol abuse
* Dementia
* QT interval (QTc) prolongation (at least 460ms in men, at least 470ms women) or drugs influencing QT interval, such as class Ia and III antiarrhythmics, Gatifloxacin, Moxifloxacin, Pentamidin, Cotrimoxazol, Tacrolimus, Dolasetron
* Parkinson's disease
* Intake of dopaminergic drugs (Levodopa, dopamine agonists)
* Parkinsonism
* Epilepsy
* Unable to be interviewed (severe Dementia, speaking disorders, intubation, respiratory isolation, aphasia, coma, terminal illness)
* Delay of operation of more than 72 hours past hospital admittance
* Body weight \>100kg

Study Locations (1)

University Hospital Basel