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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
Haloperidol 0.005mg/kg at induction of anesthesia
Ketamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium
Haloperidol 0.005mg/kg + Ketamine 1mg/kg at induction of anesthesia to test their power to prevent postoperative delirium if given together
University Hospital Basel
Basel, Switzerland
Differences among study groups - Significant drop in MMSE of two points in one of the three postoperative follow-up days
Significant drop in MMSE of two points in one of the three postoperative follow-up days (ICU patients excluded)
Time frame: 5 day follow-up (preoperative, day of surgery, postoperative days 1-3)
Quantification of incidence of postoperative delirium based on cognitive testing and lab parameters
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?)
Time frame: 5 day follow-up (preoperative, day of surgery, postoperative days 1-3)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo being used in one of the four groups