Postoperative Delirium
Conditions
Keywords
Postoperative delirium, Cortisol, NSE, S-100beta, MMSE, Nu-DESC, ICDSC, DOS, Haloperidol, Ketamine, Combination of Haloperidol and Ketamine, Placebo, Prevention of
Brief summary
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.
Detailed description
The postoperative delirium remains a challenge for medical stuff concerning detection, therapy and avoidance of consequences. Over the years numerous risk factors were detected which emphasizes the importance of its prevention. Within these studies some possibilities, but no strictly defined rules of action for pharmacological or neuropsychological prevention are described. This is why in this randomized, double-blinded, placebo-controlled study, the investigators want to compare two agents that were found to prevent postoperative delirium to a certain level, even in combination: the investigators arrange the patients within four study groups, one receiving Haloperidol, one Ketamine, one both and one placebo. The patients receive the study drug only once right before induction of anesthesia. After the day of recruitment there is the day of operation and a follow-up of three days (5 days of observation in total, where the investigators will test cognitive function with Mini Mental Status Examination (MMSE), Delirium Observation Scale (DOS), Nursing Delirium Screening Scale (Nu-DESC) or Intensive Care Delirium Screening Checklist (ICDSC). Additionally the investigators will measure and compare pre- and postoperative Cortisol, NSE and S-100beta levels.
Interventions
DRUGHaloperidol
Haloperidol 0.005mg/kg at induction of anesthesia
DRUGKetamine
Ketamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium
DRUGHaloperidol + Ketamine
Haloperidol 0.005mg/kg + Ketamine 1mg/kg at induction of anesthesia to test their power to prevent postoperative delirium if given together
Placebo being used in one of the four groups
Sponsors
Kantonsspital Baden
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences among study groups - Significant drop in MMSE of two points in one of the three postoperative follow-up days | 5 day follow-up (preoperative, day of surgery, postoperative days 1-3) | Significant drop in MMSE of two points in one of the three postoperative follow-up days (ICU patients excluded) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of incidence of postoperative delirium based on cognitive testing and lab parameters | 5 day follow-up (preoperative, day of surgery, postoperative days 1-3) | Drop of one point in Nursing Delirium Screening Scale (Nu-DESC) compared pre- and postoperatively, comparison of levels of NSE, S-100beta and Cortisol (significantly elevated postoperatively?) |
Countries
Switzerland
Outcome results
None listed